Abstract
BackgroundThe importance of 2-yr postradiotherapy prostate biopsy status remains uncertain. ObjectiveTo assess the value of 2 year post treatment biopsies in a randomised trial of radiotherapy dose escalation. Design, setting, and participantsBetween 1998 and 2001, 843 men with localised prostate cancer were randomised to receive either control-64Gy or escalated-74Gy conformal radiotherapy (CFRT) in the MRC RT01 trial in combination with 3–6-mo neoadjuvant androgen deprivation therapy. Prostate biopsies were planned at 2 yr from start of CFRT in suitable men. Outcome measurements and statistical analysisProstate biopsy results and prostate-specific antigen (PSA) levels performed at 2 yr post-CFRT were evaluated with long-term biochemical progression free survival (bPFS) and overall survival. Outcome measures were timed from the 2-yr biopsy using a landmark approach. Results and limitationsA 2-yr biopsy was performed in 312/843 patients. One hundred and seventy-seven patients were included in the per-protocol group with median follow-up of 7.8 yr from biopsy. Median PSA at biopsy was 0.5ng/ml. Sixty-four bPFS events were reported: 46/145 (32%) in patients with negative, 6/18 (33%) suspicious, and 12/14 (86%) positive biopsies. A positive biopsy was prognostic of worse bPFS, going forward, compared with negative and suspicious biopsies, hazard ratio (HR)=4.81 (95% confidence interval [CI]: 2.50–9.26, p<0.001). The estimate for survival was HR=1.58 (95% CI: 0.52–4.78, p=0.42). PSA values at 2 yr between 1.01ng/ml and 2.09ng/ml were also associated with subsequent PSA failures (HR=2.71, 95% CI: 1.98–3.71), bPFS events (HR=2.45, 95% CI: 1.81–3.32), and prostate cancer-specific survival (HR=2.87, 95% CI: 1.08–7.64) compared with PSA ≤1.0ng/ml. ConclusionsTwo-year postradiotherapy prostate biopsies have limited value in patients with PSA control but both positive biopsy and higher PSA status are strongly associated with future bPFS events. A policy of selected biopsy may provide an opportunity for early salvage interventions. Patient summaryRoutine 2-yr postradiotherapy biopsy is not recommended but can be considered in selected patients with unfavourable post-treatment prostate-specific antigen levels who are suitable for early salvage treatments.
Highlights
There is controversy over the value of prostate biopsy after radiotherapy (RT) treatment for prostate cancer in predicting future survival and recurrence trends [1,2]
Outcome measurements and statistical analysis: Prostate biopsy results and prostatespecific antigen (PSA) levels performed at 2 yr post-conformal radiotherapy (CFRT) were evaluated with long-term biochemical progression free survival and overall survival
A positive biopsy was prognostic of worse biochemical progression free survival (bPFS), going forward, compared with negative and suspicious biopsies, hazard ratio (HR) = 4.81 (95% confidence interval [CI]: 2.50–9.26, p < 0.001)
Summary
There is controversy over the value of prostate biopsy after radiotherapy (RT) treatment for prostate cancer in predicting future survival and recurrence trends [1,2]. Previous reports have suggested that men with a positive biopsy post-RT have a much worse prognosis than those with negative biopsies Most of these reports included a small number of patients, short-term follow-up, and heterogeneous methods of pathology reporting [5,6,7,8]. Outcome measurements and statistical analysis: Prostate biopsy results and prostatespecific antigen (PSA) levels performed at 2 yr post-CFRT were evaluated with long-term biochemical progression free survival (bPFS) and overall survival. Conclusions: Two-year postradiotherapy prostate biopsies have limited value in patients with PSA control but both positive biopsy and higher PSA status are strongly associated with future bPFS events. Patient summary: Routine 2-yr postradiotherapy biopsy is not recommended but can be considered in selected patients with unfavourable post-treatment prostate-specific antigen levels who are suitable for early salvage treatments
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