Two-years Postradiotherapy Biopsies: Lessons from MRC RT01 Trial.
Eur Urol
; 73(6): 968-976, 2018 06.
Article
in En
| MEDLINE
| ID: mdl-29307509
ABSTRACT
BACKGROUND:
The importance of 2-yr postradiotherapy prostate biopsy status remains uncertain.OBJECTIVE:
To assess the value of 2 year post treatment biopsies in a randomised trial of radiotherapy dose escalation. DESIGN, SETTING, ANDPARTICIPANTS:
Between 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 STATISTICALANALYSIS:
Prostate 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 ANDLIMITATIONS:
A 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.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. A policy of selected biopsy may provide an opportunity for early salvage interventions. PATIENTSUMMARY:
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Prostate
/
Prostatic Neoplasms
/
Prostate-Specific Antigen
Type of study:
Clinical_trials
/
Guideline
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Aged
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Eur Urol
Year:
2018
Type:
Article
Affiliation country:
United kingdom