Prostate
Post-RP fossa RT: the QOL cost of adjuvant over salvage, from the trial that already showed no efficacy penalty for waiting.
TROG 08.03 RAVES QOL Substudy
ForPost-RP prostate cancer with adverse pathology (margins, EPE, or SVI)
Severe urinary leakage 16% vs 2%
aRT vs no RT at 5 yr, p = 0.01
TL;DRSevere urinary leakage 16% vs 2% at 5yr with aRT vs no RT; timing of salvage RT unrelated to QOL.
The QOL benefit of a salvage approach is avoidance, not delay: 52% of the sRT arm never needed RT, and among men who did get RT, severe urinary leakage at 5 yr was the same whether early or late (16% vs 13%, p = 0.7), with no coefficient linking RP-to-RT interval to any domain. Dose was 64 Gy/32 fx fossa-only, no ADT, no nodes.
For a man with adverse pathology after RP and an undetectable PSA, this supports PSA surveillance with early salvage rather than adjuvant RT on functional grounds; it does not speak to men needing ADT, pelvic nodal RT, or Gleason 9 disease, who were sparse or excluded here.
Delay buys nothing functionally: among men who received RT, severe urinary leakage at 5 yr was 16% aRT vs 13% sRT (p = 0.7) and no RP-to-RT interval coefficient reached significance. The advantage of a salvage policy is that 52% of that arm never needed RT. Dose was 64 Gy/32 fx fossa-only, 3D-CRT era, no ADT or nodes.
For counselling after RP with adverse pathology, the functional cost quoted to a man should be conditional on recurring: irradiated men reported severe urinary leakage of 16% at 5 yr against 2% in those never irradiated, but that no-RT group is defined by not recurring, not by randomization. Continence counselling is unchanged by RT timing.
11 details
Protocol-planned secondary analysis of the TROG 08.03 RAVES phase 3 noninferiority RCT, 166 aRT vs 167 sRT. Median follow-up 6 yr (IQR 4 to 7.1) in both arms. Complete-case analysis, no imputation, chi-square per timepoint.
High-risk features after RP: positive margins, extraprostatic extension, or seminal vesicle invasion. 82% Gleason 7, 3% Gleason 8, 12% Gleason 9. Median age 63.8 vs 63.9 yr (p = 0.9).
64 Gy in 32 fractions to the prostate fossa in both arms, mostly 3D-CRT rather than IMRT. aRT within 6 mo of RP; sRT triggered at PSA 0.20 ng/ml and delivered within 4 mo. Concurrent ADT and pelvic nodal treatment were not permitted.
Primary: proportion with a minimal clinically important change, defined as a >0.5 SD decline from baseline on each QLQ-PR25 domain. MCIC thresholds were 7 points urinary, 2 points bowel, 14 sexual activity, 12 sexual functioning. Global QOL by QLQ-C30.
The RP-to-RT interval regression is the cleanest read: no coefficient approached significance at 3, 4, or 5 yr in any domain, with the largest estimate 0.20 (95% CI -0.29 to 0.70, p = 0.4).
| Endpoint at 5 yr | Adjuvant RT | No RT | p |
|---|---|---|---|
| MCIC bowel symptoms | 37% (40/109) | 12% (6/50) | not reported in source |
| Severe urinary leakage | 18/111 (16) | 1/50 (2) | 0.01 |
| Severe urinary leakage at 4 yr | 15/124 (12) | 1/59 (1.7) | 0.02 |
| Urinary urgency | 18/110 (16) | 3/50 (6) | 0.072 |
GETUG-AFU 17 and RADICALS reported the same directional late GU penalty for adjuvant RT, though cross-trial comparison is blocked by differing urinary grading. Prior clinician-rated series put CTCAE grade 2 incontinence at 10 to 20%, bracketing the 16% seen here.
The aRT versus never-irradiated comparison is not randomized: those 87 men were selected by not recurring, so comorbidity and baseline continence are unbalanced by construction. The sRT-received group's worse sexual activity at 3 and 4 yr is confounded by higher-risk disease and likely more ADT off-protocol, and the 5-yr sexual functioning cells are as small as n = 10.
The patient-reported bowel signal is invisible on CTCAE (RAVES showed no clinician-rated GI difference), and the patient-reported urinary trend never reached consistent significance despite a 70% vs 54% clinician-rated G2+ GU gap. The two instruments are measuring different things, and neither alone describes what a man experiences.
CONSORT flow
Protocol-planned secondary analysis of a randomized trial; supports the established early-salvage standard. Exploratory, unadjusted for multiple testing, 3D-CRT era.
- Long-term patient-reported QOL with hypofractionated postprostatectomy RT
- QOL impact of adding short-course ADT and pelvic nodal RT post-RP
- Whether IMRT eliminates the patient-reported bowel signal