Low-risk Localized Prostate Cancer Research Articles

Surgical techniques and short-term outcomes of transvesical robot assisted radical prostatectomy

Objective To introduce the technique and report our initial experience of transvesical robot assisted radical prostatectomy (TvRARP). Methods From April 2018 to August 2018, 10 patients underwent TvRARP performed by a single surgical team were retrospectively reviewed. Preoperative data of patients [aged (58.6±9.4) years, BMI (26.5±3.1) kg/m2, tPSA (19.5±4.1) ng/ml, biopsy Gleason score 6(6-7), prostate volume (33.4±15.8)ml and IIEF-5 score 12(10-16)] were collected. Preoperative study revealed 8 cases of cT1c, 1 case of cT2a and 1 case of cT2b. All patients were continent preoperatively. During the surgical procedure, the bladder was opened, and a circumferential incision was then made around the internal urethral orifice. Initially, posterior dissection of bilateral vas deferens and seminal vesicles was performed, followed by posterior dissection towards apex. Lateral dissection of neurovascular bundles was performed before anterior dissection towards apex. The exposed urethra was transected and specimen was removed. Vesicourethral anastomosis and closure of bladder was performed in a standard way. Results All 10 cases were successfully performed robotically without conversion, transfusion or other major intraoperative or postoperative complications. Postoperative pathology confirmed 6 cases of pT2a , 3 cases of pT2b and 1 case of pT2c [median Gleason score 6(6-7)]. One case was reported positive surgical margin. Operative time was (140.5±35.5) mins. Estimated blood loss was (65.5±35.5) ml. Urethral catheter was removed at 7 days postoperatively. Nine patients achieved urinary continence (0 pads) immediately after the removal of urinary catheter, while 1 patient returned to full continence at 2 weeks postoperatively. During a mean follow-up of 3 months (2-4 months), no biochemical recurrence was detected (tPSA 0.05). Conclusions Transvesical approach is a valid alternative of RARP in patients bearing localized low-risk prostate cancer. Tumor control and preservation of erectile function remains to be determined by long term follow-up. Key words: Radical prostatectomy; Robot; Transvesical approach; Localized prostate cancer

Long Term Results of Cs-131 Monotherapy as Definitive Therapy in a Prospectively-Followed Group of Low Risk Localized Prostate Cancer Patients

Cesium-131 has been available as a permanently implantable brachytherapy source since 2005. Published long-term biochemical control rates for the earlier available Iodine-125 and Palladium-103 sources in the treatment of localized prostate cancer have been available prior to the introduction of Cesium-131. As a result, some question remains as to the long-term performance of Cesium-131 in establishing biochemical control in the localized prostate cancer patient relative to the other two radio-isotopes. A large prospective database maintained since 2000 was queried for low risk prostate cancer patients treated with Cesium-131 monotherapy prior to 2010 and for whom PSA follow-up data was available. “Low risk” was defined per NCCN guidelines as Gleason 3+3 or less disease at diagnostic biopsy, diagnostic serum PSA <= 10 ng/ml and clinical stage T2a or less. A total of 261 patients were available for analysis per the query criteria. Mean/median diagnostic PSA were 5.6 / 5.4 ng/ml, respectively. 99% of patients were graded as Gleason 3+3, and clinical stage was T1c in 91%. Median follow-up for the group was 66.9 months. A total of 2,847 follow-up PSA measurements were analyzed for the group, an average of 10.9 per patient. Eighteen (18) patients (7%) underwent three months of hormonal therapy prior to implant for the purpose of gland downsizing. The Phoenix definition was used to score each patient as a failure or censored observation. Failure time was determined at call and no further follow-up data was considered for failed patients. Patients who exhibited no rises or exhibited a “bounce” (a rise above nadir where subsequent PSA profile showed a downward trend) were censored at last follow-up. 10 patients (3.8%) were scored as failures. Kaplan-Meier functions returned BRFS rates of 97% at 5 years (155 at risk); 94% at 8 years (75 at risk); 93% at 9 years (47 at risk), and 90% at 10 years (19 at risk). This analysis represents the longest followed series of Cesium-131 patients reported to-date. The closely followed and mature nature of this large prospective group of uniformly low risk patients provides strong evidence for the efficacy of Cesium-131 monotherapy in this setting per biochemical endpoint analysis.

P89 - Anxiety levels at diagnosis and after 6 months in localized low-risk prostate cancer who choose radical treatment or active surveillance: Results of the start study group

P89 - Anxiety levels at diagnosis and after 6 months in localized low-risk prostate cancer who choose radical treatment or active surveillance: Results of the start study group

Germline mutations in PPFIBP2 are associated with lethal prostate cancer.

Few genes have germline mutations which predispose men to more aggressive prostate cancer (PCa). This study evaluated the contribution of germline loss of function (LOF) variants in PPFIBP2 to risk of lethal PCa. A case-case study of 1414 PCa patients with lethal PCa and low-risk localized PCa was performed. Germline DNA samples from these patients were sequenced for PPFIBP2. Mutation carrier rates and association with lethal PCa were analyzed using the Fisher exact test, logistic regression, and Kaplan-Meier survival analysis. In the entire study population, eight patients, all of European ancestry, were identified as carrying PPFIBP2 pathogenic or likely pathogenic mutations. Seven (1.52%) of 462 lethal PCa patients were carriers compared with only one (0.12%) carrier in 810 low-risk PCa patients, P = 0.0029. The estimated Odds Ratio (OR) of carrying PPFIBP2 mutation for lethal PCa was 13.8 in European American population. The PPFIBP2 loss-of-function mutation carrier rate in lethal PCa cases was also higher than in 33 370 non-Finnish European individuals from the Exome Aggregation Consortium (ExAC) (carrier rate of 0.17%, P = 1.92 × 10-5 ) and in 498 men with localized PCa from The Cancer Genome Atlas cohort (TCGA) cohort (carrier rate of 0%, P = 0.0058). Survival analysis in European American lethal cases revealed PPFIBP2 mutation status as an independent predictor of shorter survival after adjusting for age at diagnosis, PSA at diagnosis, and genetic background (hazard ratio = 2.62, P = 0.034). While larger studies are needed, germline mutations in a novel gene, PPFIBP2, differentiated risk for lethal PCa from low-risk cases and were associated with shorter survival times after diagnosis.

High-intensity focused ultrasound therapy for the treatment of prostate cancer: Medium-term experience

IntroductionThe treatment of localized prostate cancer seeks to minimize the impact on sexual function and urinary continence. In this respect, therapy with high-intensity focused ultrasound offers important results. We present our experience with this technique in 2 Spanish centers. Material and methodsWe conducted a retrospective review of 75 patients with localized prostate cancer treated with high-intensity focused ultrasound between March 2007 and July 2016. The oncological results and perioperative complications were assessed, as well as the impact on sexual function and continence. ResultsA total of 67 patients were analyzed. The mean follow-up was 7.2 years. The PSA nadir was 0.2ng/ml (0–3), 24 patients (35.5%) presented biochemical recurrence, and 18 underwent a further biopsy, with 10 cases (55.5%) presenting disease recurrence. The overall biochemical relapse-free survival at 5 and 8 years was 93.2 and 80.5%, respectively. The cancer-specific survival at 5 and 8 years was 96% in both cases. In the postoperative period, 50 patients (74.6%) were continent, 16 (23.9%) reported mild incontinence, and one (1.5%) reported moderate incontinence. The median International Index of Erectile Function-5 before and after the surgery was 17 (5–25) and 16 (2–23) points, respectively. Nine patients reported de novo erectile dysfunction (13.5%). ConclusionHigh-intensity focused ultrasound appears to be a safe alternative for the treatment of localized prostate cancer, especially for low-risk localized prostate cancer. In our experience, this technique offers advantages in preserving urinary continence, and the medium-term oncological results are encouraging. Given the natural progression of prostate cancer, long-term studies with a larger number of cases are needed to corroborate these results.

Medium-term Follow-up of Vascular-targeted Photodynamic Therapy of Localized Prostate Cancer Using TOOKAD Soluble WST-11 (Phase II Trials)

Background and objectiveTo assess the medium-term tumor control in patients with localized prostate cancer (PCa) treated with vascular-targeted photodynamic (VTP) therapy with TOOKAD Soluble WST11 (VTP) and to assess the medium-term tolerability of the treatment. Design, setting, participants, and interventionDuring the clinical phase II studies, 68 patients were treated with VTP under optimal treatment conditions (WST11 at 4mg/kg, light energy at 200J/cm, and a light density index ≥1) and have been included in a 3.5-yr follow-up. Outcome measurements and statistical analysisPost-interventional visits were scheduled every 6 mo and conducted as per local standard practice in each study center. Cancer-free status was assessed by means of prostate-specific antigen kinetics, multiparametric magnetic resonance imaging and/or prostate biopsies. Results and limitationsAt the end of the 3.5-yr follow-up, overall successful focal ablation was achieved for 51 patients (75%). Cancer was identified in the untreated lobe in 17 patients (25%). In total, 34 patients (50%) were cancer-free in both the prostate lobes. In case of recurrent/persistent malignancy, the Gleason score remained consistent or changed at the maximum by one point (upgrading by 1 Gleason point to 3+4 for eight patients and 4+3 for two patients). There were 64 related adverse events (AEs): 48% were Clavien grade I, 47% were grade II, and 5% were grade III. There were no Clavien grade IV and V AEs. Limitations included small sample size and heterogeneity in the follow-up for some centers. ConclusionsVTP is a safe and efficient treatment and represents an alternative option for localized low-risk PCa management over the medium term. Precise diagnostic methods and imaging tools are thereby essential requirements to ensure safe and complete targeted therapy. Patient summaryIn this report, we looked at the medium-term outcomes of focal photodynamic therapy for early-stage prostate cancer. We found that this form of treatment is efficient and might have the potential to become a therapeutic option for low-risk cancer. Effectiveness depends on precise diagnostic methods, such as magnetic resonance imaging and accurate biopsy.

Terapia ultrasonido focalizado de alta intensidad (HIFU) para el tratamiento del cáncer de próstata: Experiencia a medio plazo

IntroductionThe treatment of localised prostate cancer seeks to minimise the impact on sexual function and urinary continence. In this respect, therapy with high-intensity focused ultrasound offers important results. We present our experience with this technique in 2 Spanish centres. Material and methodsWe conducted a retrospective review of 75 patients with localised prostate cancer treated with high-intensity focused ultrasound between March 2007 and July 2016. The oncological results and perioperative complications were assessed, as well as the impact on sexual function and continence. ResultsA total of 67 patients were analysed. The mean follow-up was 7.2 years. The PSA nadir was 0.2ng/mL (0-3), 24 patients (35.5%) presented biochemical recurrence, and 18 underwent a further biopsy, with 10 cases (55.5%) presenting disease recurrence. The overall biochemical relapse-free survival at 5 and 8 years was 93.2 and 80.5%, respectively. The cancer-specific survival at 5 and 8 years was 96% in both cases. In the postoperative period, 50 patients (74.6%) were continent, 16 (23.9%) reported mild incontinence, and one (1.5%) reported moderate incontinence. The median International Index of Erectile Function-5 before and after the surgery was 17 (5-25) and 16 (2-23) points, respectively. Nine patients reported de novo erectile dysfunction (13.5%). ConclusionHigh-intensity focused ultrasound appears to be a safe alternative for the treatment of localised prostate cancer, especially for low-risk localised prostate cancer. In our experience, this technique offers advantages in preserving urinary continence, and the medium-term oncological results are encouraging. Given the natural progression of prostate cancer, long-term studies with a larger number of cases are needed to corroborate these results.

A comprehensive evaluation of CHEK2 germline mutations in men with prostate cancer.

Germline mutations in CHEK2 have been associated with prostate cancer (PCa) risk. Our objective is to examine whether germline pathogenic CHEK2 mutations can differentiate risk of lethal from indolent PCa. A case-case study of 703 lethal PCa patients and 1455 patients with low-risk localized PCa of European, African, and Chinese origin was performed. Germline DNA samples from these patients were sequenced for CHEK2. Mutation carrier rates and their association with lethal PCa were analyzed using the Fisher exact test and Kaplan-Meier survival analysis. In the entire study population, 40 (1.85%) patients were identified as carrying one of 15 different germline CHEK2 pathogenic or likely pathogenic mutations. CHEK2 mutations were detected in 16 (2.28%) of 703 lethal PCa patients compared with 24 (1.65%) of 1455 low-risk PCa patients (P = 0.31). No association was found between CHEK2 mutation status and early-diagnosis or PCa-specific survival time. However, the most common mutation in CHEK2, c.1100delC (p.T367 fs), had a significantly higher carrier rate (1.28%) in lethal PCa patients than low-risk PCa patients of European American origin (0.16%), P = 0.0038. The estimated Odds Ratio of this mutation for lethal PCa was 7.86. The carrier rate in lethal PCa was also significantly higher than that (0.46%) in 32 461 non-Finnish European subjects from the Exome Aggregation Consortium (ExAC) (P = 0.01). While overall CHEK2 mutations were not significantly more common in men with lethal compared to low-risk PCa, the specific CHEK2 mutation, c.1100delC, appears to contribute to an increased risk of lethal PCa in European American men.

Low-dose-rate brachytherapy as a minimally invasive curative treatment for localised prostate cancer has excellent oncological and functional outcomes: a retrospective analysis from a single centre.

IntroductionLow-dose-rate (LDR) brachytherapy is a widely used therapeutic option for localised prostate cancer. The aim of this study was to analyse the oncological and functional outcomes after 10 years of experience with brachytherapy for localised prostate cancer.Material and methodsAll patients who underwent brachytherapy between April 2006 and September 2017 were included for analysis. Initial prostate-specific antigen (PSA) levels, tumour stages, Gleason scores, positive biopsies, prostate volumes, dosimetric parameters, and urinary symptoms were noted.ResultsA total of 201 patients underwent brachytherapy between April 2006 and September 2017. Of these patients, 159 had >3 years of oncological and functional follow-up. Only these relevant patients were included in the statistical analysis. This showed a significant, persistent decline in PSA levels (p <0.0001): the mean PSA was 1.2 ng/ml after 6 months, 1.1 ng/ml after 1 year, and 0.49 ng/ml after 3 years. Only 9 patients had tumour recurrence (3 patients with Gleason score 6 and 6 patients with Gleason score 7). After receiving adequate treatment, the patients underwent oncological follow-up.Important obstructive and irritative complaints were most pronounced during the first 9 months and decreased strongly after 18 months of follow-up.ConclusionsLDR brachytherapy has excellent oncological outcomes with limited functional inconveniences that are adequately treatable. Our 10 years' experience shows that brachytherapy is a safe and effective method for the treatment of low-risk localised prostate cancer.

Comparative Analysis of Harms Associated with Conservative Management and Immediate Treatment among Low Risk Localized Prostate Cancer Patients: A Population Based Study

Comparative Analysis of Harms Associated with Conservative Management and Immediate Treatment among Low Risk Localized Prostate Cancer Patients: A Population Based Study

Comparison of intrafascial and non-intrafascial radical prostatectomy for low risk localized prostate cancer

In this meta-analysis study, we compared the oncological and functional outcomes of intrafascial radical prostatectomy (IFRP) with non-intrafascial radical prostatectomy (NIFRP) in the treatment of patients with low risk localized prostate cancer (PCa). Relevant articles were identified by searching PubMed, EMBASE, Cochrane Library, Ovid, and the ISI Web of Knowledge databases. A total of 2096 patients were included from 7 eligible studies. Results of the pooled data showed that the oncological outcomes including gleason score, positive surgical margin and biochemical free survival rates were similar between the two groups. IFRP was superior to NIFRP with lower postoperative complication rates (RR 0.57, 95% CI 0.38, 0.85, p = 0.006), higher continence rates at 3 months post-operation (RR: 1.14; 95% CI, 1.04, 1.26; p = 0.006), and higher potency rates at 6 months (RR: 1.53; 95% CI, 1.07, 2.18; p = 0.02) and 12 months post-operation (RR: 1.38; 95% CI, 1.11, 1.73; p = 0.005). Additionally, there was a tendency towards higher potency rate in patients ≤65 years old compared with patients >65 years old after IFRP. Overall, these findings suggest that IFRP in young patients with low risk localized PCa had less postoperative complications, shortened time to return to continence and improved potency rate without compromising complete tumor control.

Re: Long-term Psychological and Quality-of-life Effects of Active Surveillance and Watchful Waiting After Diagnosis of Low-risk Localised Prostate Cancer

Re: Long-term Psychological and Quality-of-life Effects of Active Surveillance and Watchful Waiting After Diagnosis of Low-risk Localised Prostate Cancer

Active surveillance for localized prostate cancer: update of a prospective single-center cohort

Objective: The purpose of active surveillance (AS) is to reduce overtreatment of men with localized prostate cancer (PCa) without compromising survival. The objective of this study was to update a large Scandinavian single-center AS cohort. Furthermore, the use of curative treatment and subsequent risk of biochemical recurrence were investigated and compared in men with very low-risk, low-risk and intermediate-risk PCa in the cohort.Materials and methods: In total, 451 men were followed on AS and monitored with prostate-specific antigen (PSA) tests, digital rectal examinations and rebiopsies. Recommendation of curative treatment was based on protocolled and predefined risk of progression criteria. Biochemical recurrence was defined as PSA ≥0.2 ng/ml after radical prostatectomy and PSA nadir +2 ng/ml after radiotherapy.Results: Altogether, 34% were defined with very low-risk PCa, 40% with low-risk PCa and 24% with intermediate-risk PCa. The median follow-up was 5.1 years. The estimated 5 year curatively intended treatment-free survival was 60.5% [95% confidence interval (CI) 54.8–66.2%], with no statistically significant difference between men with very low-risk, low-risk or intermediate-risk PCa. The 5 year biochemical recurrence-free survival was 92.3% (95% CI 87.4–97.2), again with no difference between men with very low-risk, low-risk and intermediate-risk PCa.Conclusion: AS for very low- to low-risk localized PCa is feasible and safe within the short to intermediate time frame. Men with intermediate-risk PCa had the same risk of undergoing curative treatment as men with low-risk PCa, without compromising biochemical recurrence-free survival.

Long-term Psychological and Quality-of-life Effects of Active Surveillance and Watchful Waiting After Diagnosis of Low-risk Localised Prostate Cancer

BackgroundLong-term psychological well-being and quality-of-life are important considerations when deciding whether to undergo active treatment for low-risk localised prostate cancer. ObjectiveTo assess the long-term effects of active surveillance (AS) and/or watchful waiting (WW) on psychological and quality-of-life outcomes for low-risk localised prostate cancer patients. Design, setting, and participantsThe Prostate Cancer Care and Outcome Study is a population-based prospective cohort study in New South Wales, Australia. Participants for these analyses were low-risk localised prostate cancer patients aged <70 yr at diagnosis and participated in the 10-yr follow-up. Outcome measurements and statistical analysisValidated instruments assessed outcomes relating to six health-related quality-of-life and nine psychological domains relevant to prostate cancer patients. Adjusted mean differences (AMDs) in outcome scores between prostate cancer treatment groups were estimated using linear regression. Results and limitationsAt 9–11 yr after diagnosis, patients who started AS/WW initially had (1) higher levels of distress and hyperarousal than initial radiation/high-dose-rate brachytherapy patients (AMD=5.9; 95% confidence interval or CI [0.5, 11.3] and AMD=5.4; 95% CI [0.2, 10.5], respectively), (2) higher levels of distress and avoidance than initial low-dose-rate brachytherapy patients (AMD=5.3; 95% CI [0.2, 10.3] and AMD=7.0; 95% CI [0.5, 13.5], respectively), (3) better urinary incontinence scores than initial radical prostatectomy patients (AMD=–9.1; 95% CI [–16.3, –2.0]), and (4) less bowel bother than initial radiation/high-dose-rate brachytherapy patients (AMD=–16.8; 95% CI [–27.6, –6.0]). No other significant differences were found. Limitations include participant attrition, inability to assess urinary voiding and storage symptoms, and nonrandom treatment allocation. ConclusionsNotwithstanding some long-term differences between AS/WW and various active treatment groups in terms of distress, hyperarousal, avoidance, urinary incontinence, and bowel bother, most long-term outcomes were similar between these groups. Patient summaryThis study assessed the long-term psychological and quality-of-life impacts of initially monitoring rather than actively treating low-risk prostate cancer. The results suggest that initial monitoring rather than active treatment has only a minor impact on subsequent long-term psychological and quality-of-life outcomes.

Hypo-fractionated SBRT for localized prostate cancer: a German bi-center single treatment group feasibility trial

BackgroundFor prostate cancer treatment, treatment options with minimal side effects are desired. External beam radiation therapy (EBRT) is non-invasive, standard of care and delivered in either conventional fractionation over 8 weeks or with moderate hypo-fractionation over about 5 weeks. Recent advances in radiotherapy technology have made extreme hypo-fractionated stereotactic body radiation therapy (SBRT) of prostate cancer feasible, which has not yet been introduced as a standard treatment method in Germany. Initial results from other countries are promising, but long-term results are not yet available. The aim of this study is to investigate feasibility and effectiveness of SBRT for prostate cancer in Germany.Methods/designThis German bi-center single group trial (HYPOSTAT) is designed to evaluate feasibility and effectiveness, as measured by toxicity and PSA-response, respectively, of an extreme hypo-fractionated SBRT regimen with five fractions of 7 Gy in treatment of localized low and intermediate risk prostate cancer. The target volume includes the prostate with or without the base of seminal vesicles depending on risk stratification and uncertainty margins that are kept at 3–5 mm. SBRT treatment is delivered with the robotic CyberKnife system, which was recently introduced in Germany. Acute and late toxicity after one year will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE v. 4.0), Radiation Therapy Oncology Group (RTOG) and International Prostate Symptom Score (IPSS) Scores. The quality of life will be assessed before and after treatment with the EORTC QLQ C30 questionnaire. Hypothesizing that the proportion of patients with grade 2 side effects or higher is less or equal than 2.8%, thus markedly lower than the standard EBRT percentage (17.5%), the recruitment target is 85 patients.DiscussionThe HYPOSTAT trial aims at demonstrating short term feasibility of extreme hypo-fractioned SBRT for the treatment of prostate cancer and might be used as the pilot study for a multi-center multi-platform or for randomized-controlled trials comparing conventional radiotherapy with SBRT for localized prostate cancer in the future. The study concept of patient enrollment, follow up and evaluation by multiple public university clinics and actual patient treatment in dedicated private radiosurgery practices with high-tech radiation equipment is unique for clinical trials.Study statusThe study is ongoing and currently recruiting patients.Trial registrationRegistration number: NCT02635256 (clinicaltrials.gov). Registered 8 December 2015.

The cost-effectiveness of active surveillance compared to watchful waiting and radical prostatectomy for low risk localised prostate cancer

BackgroundRadical prostatectomy is the most common treatment for localised prostate cancer in New Zealand. Active surveillance was introduced to prevent overtreatment and reduce costs while preserving the option of radical prostatectomy. This study aims to evaluate the cost-effectiveness of active surveillance compared to watchful waiting and radical prostatectomy.MethodsMarkov models were constructed to estimate the life-time cost-effectiveness of active surveillance compared to watchful waiting and radical prostatectomy for low risk localised prostate cancer patients aged 45–70 years, using national datasets in New Zealand and published studies including the SPCG-4 study. This study was from the perspective of the Ministry of Health in New Zealand.ResultsRadical prostatectomy is less costly than active surveillance in men aged 45–55 years with low risk localised prostate cancer, but more costly for men aged 60–70 years. Scenario analyses demonstrated significant uncertainty as to the most cost-effective option in all age groups because of the unavailability of good quality of life data for men under active surveillance. Uncertainties around the likelihood of having radical prostatectomy when managed with active surveillance also affect the cost-effectiveness of active surveillance against radical prostatectomy.ConclusionsActive surveillance is less likely to be cost-effective compared to radical prostatectomy for younger men diagnosed with low risk localised prostate cancer. The cost-effectiveness of active surveillance compared to radical prostatectomy is critically dependent on the ‘trigger’ for radical prostatectomy and the quality of life in men on active surveillance. Research on the latter would be beneficial.

Abstract CT103: A phase II study to evaluate outpatient magnetic resonance image-guided laser focal therapy for prostate cancer: A 20-year survival study (seven-year interim results)

Abstract Purpose: In the United States alone, new prostate cancer cases for 2016 were estimated at 180,890 and deaths at 26,120. Focal therapies for low risk and intermediate risk localized prostate cancer are increasingly being explored. Additionally, new treatments for patients with biochemical recurrence of prostate cancer are also under investigation. Our objective is to investigate the safety and feasibility of using outpatient MR-guided laser focal therapy for MR visible prostate cancer utilizing a transrectal approach for laser applicator placement and therapy delivery in an outpatient setting. Method and Materials: All MRI-guided therapy was delivered using a 1.5 Tesla MRI system for both image acquisition and real-time thermometry. Commercially available hardware and software were used for image analysis and interventional planning. Laser therapy was delivered using a 15W, 980 nm diode laser applicator with fiber-cooling catheter introduced transrectally using a commercially available MRI-compatible introducer system. Results: 80 men were treated. 112 cancer foci were treated. Total procedure time was between 1.5 and four hours MRI volume of coagulation necrosis ranged from 0.57 to 22.93 cc. No serious adverse events or morbidity were reported. 17 treatment regions were positive at six months biopsy, consistent with residual or recurrent cancer 26% of subjects 18% of treated regions.We observed a 40% decrease in mean PSA at 1 year post therapy and no statistically significant change in IPSS and SHIM scores at 6 months post-treatment. Conclusion: Our data indicate that outpatient, transrectally delivered MRI-guided laser focal therapy for prostate cancer is both safe and feasible. Clinical Relevance/Application: In the current climate of cost-reduction and emphasis on minimally-invasive treatment of cancer, focal treatment of prostate cancer may be an attractive option. The precise energy delivery under MRI-guidance may have favorable results for cost control and quality of life without eliminating the possibility of whole-gland treatment in the patient’s future. Citation Format: Bernadette Marie Greenwood, John F. Feller, Stuart T. May, Wes Jones, Axel Winkel. A phase II study to evaluate outpatient magnetic resonance image-guided laser focal therapy for prostate cancer: A 20-year survival study (seven-year interim results) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr CT103. doi:10.1158/1538-7445.AM2017-CT103

Choosing Wisely in Cancer Control across Canada—A Set of Baseline Indicators

Value-based care, which balances high-quality care with the most efficient use of resources, has been considered the next frontier in cancer care and a means to maintain health system sustainability. Created to promote value-based care, Choosing Wisely Canada-modelled after Choosing Wisely in the United States-is a national clinician-driven campaign to identify unnecessary or harmful services that are frequently used in Canada. As part of the campaign, national medical societies have developed recommendations for tests and treatments that clinicians and patients should question. Here, we present baseline indicator findings about current practice patterns associated with 7 cancer-related recommendations from Choosing Wisely Canada and about the effects of those practices on patients and the health care system. Indicator findings point to substantial variations in cancer system performance between Canadian jurisdictions, most notably for breast cancer screening practices, treatment practices for men with low-risk localized prostate cancer, and radiation therapy practices for early-stage breast cancer and bone metastases. Extrapolating indicator findings to the entire country, it was estimated that 740,000 breast and cervical cancer screening tests were performed outside of the recommended age ranges, and within 1 year of diagnosis, 17,000 patients received treatments that could be low-value. A 15% reduction in the use of the 7 screening and treatment practices examined could lead to multiple benefits for patients and the health care system: 9000 false-positive results and 3000 treatments and related side effects could be avoided, and 4500 hours of linear accelerator capacity could be freed up each year. Interjurisdictional performance variations suggest potential differences in clinical practice patterns in the planning and delivery of cancer control services, and in some cases, in disease management outcomes. Although the cancer screening and treatment practices described might be unnecessary for some patients, it is important to realize that they could, in fact, be necessary for other patients. Further research into appropriate rates of use could help to determine how much cancer care represents overuse of practices that are not supported by evidence or underuse of practices that are supported by evidence.

1058 - Population-based analysis: Changes in the natural history of low risk localized prostate cancer

1058 - Population-based analysis: Changes in the natural history of low risk localized prostate cancer

Nationwide analysis: Changes in the natural history of low risk localized prostate cancer.

12 Background: Increased use of prostate-specific antigen (PSA) has introduced an increase in PCa incidence and a lead time and stage migration at diagnosis, altering the natural history of PCa. Contemporary PCa patients are likely younger and have smaller tumor burden at diagnosis. We investigated if changes in the PCa landscape have altered the course of low-risk localized PCa. Methods: In the Danish Prostate Cancer Registry (DaPCaR), patients diagnosed from 1995 to 2011 with localized (T1-2, N0/X, M0) PCa with Gleason score ≤ 6 were identified. Patients were stratified into three periods of diagnosis; 1995-2000 (period 1), 2001-2005 (period 2) and 2006-2011 (period 3). Competing risk analysis treating PCa and other-cause death as competing events was performed. Results: Of the 5,660 patients identified, 35.9% had undergone radical prostatectomy (RP). From period 1 to period 3, the median age at diagnosis decreased from 72.2 to 66.0 years and the median PSA decreased from 16.2 to 8.6 ng/mL. From period 1 to period 3, the 5-year risk of PCa-death decreased from 14.3% (95% CI: 12.1-16.4%) to 1.3% (95% CI: 0.83-1.7%), p &lt; .0.0001 and the risk of other cause death decreased from 18.1% (95% CI: 15.8-20.5%) to 7.2% (95% CI: 6.2-8.2), p = 0.0001. In patients undergoing RP, the 5-year risk of PCa-death decreased from 0.67% (95% CI: 0.67-2.0%) for patients diagnosed in period 1 to 0.45% (95% CI: 0.0055-0.84), for patients diagnosed in period 3, p = 0.92. For patients not undergoing RP, the 5-year risk of PCa death decreased from 16.6% (95% CI: 14.1-19.1) to 2.0% (95% CI: 1.2-2.7%), p &lt; 0.0001. Conclusions: In a nationwide cohort of patients with low risk localized PCa, the 5-year risk of PCa-death significantly decreased when comparing patients diagnosed during 2006-2011 to those diagnosed during 1995-2000. This was mainly driven by patients not undergoing RP. In the most recently diagnosed group, the difference in 5-year PCa-death between patients undergoing RP and not undergoing RP was small (0.45% vs. 2.0%). Our data demonstrate that the impact of PSA induced lead-time and stage migration has diminished the absolute effect of RP on the risk of 5-year PCa-death because contemporary low-risk localized patients have a significantly better prognosis.