Radiotherapy following radical prostatectomy - Adjuvant Versus Early Salvage

Trans Tasman Radiation Oncology Group (TROG) 08.03 - A Phase III Multi-Centre Randomised Trial Comparing biochemical failure following Adjuvant Radiotherapy (RT) versus Early Salvage RT in Patients With Positive Margins or Extraprostatic Disease Following Radical Prostatectomy.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000781943

Acronym

RAVES

Enrollment

333

Registered

2011-07-26

Start date

2009-03-30

Completion date

2015-12-31

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to compare two different radiotherapy regimes following radical prostatectomy in men with prostate cancer. Who is it for? You may be eligible to join this study if you a male aged 18 years or above who has undergone a radical prostatectomy (RP) for prostate cancer, and are able to start radiotherapy within 4 months of RP. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current standard of care treatment, which consists of adjuvant radiation therapy (ART) commenced within 4 months of radical prostatectomy. Participants in the other group will instead undergo active surveillance, where salvage radiotherapy (SRT) will not commence until Prostate Specific Antigen (PSA) reaches a level greater than 0.2ng/ml. Both radiotherapy regimes will be delivered once per day over approximately 6.5 weeks. Quality of life self-assessment questionnaires, Hospital Anxiety and Depression Score and toxicity will be assessed at baseline, the end of radiotherapy and annually for 5 years. Patients will be seen by their doctor 6 monthly for the first 5 years, then annually for the next 5 years. A blood test measuring PSA is done 3 monthly for the first 5 years for patients randomised to early SRT, than 6 monthly from years 5-10.

Interventions

Arm 1: Standard Arm - Adjuvant Radiotherapy. Radiation: Adjuvant radiation therapy (ART) commenced within 4 months of Radical Prostatectomy (RP). 64Gy in 32 fractions to the prostate bed, radiotherapy will be delivered 1 fraction/day over approx 6.5 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Prior radical prostatectomy (RP) for adenocarcinoma of the prostate. 2. Histological confirmation of adenocarcinoma of the prostate with Gleason score reported (RP specimen). 3. Patients must have at least one of the following risk factors: a) positive margins, b) extraprostatic extension (EPE) with or without seminal vesicle involvement (pT3a or pT3b). 4. Capable of starting RT within 4 months of RP (a requirement if randomised to adjuvant RT arm). 5. Most recent PSA <= 0.1ng/ml following RP and prior to randomisation. 6. European Cooperative Oncology Group (ECOG) performance status 0-1. 7. Patient able to adhere to the specified follow-up schedule and complete the Quality Of Life and anxiety/depression self assessments. 8. Written informed consent obtained prior to randomisation. 9. Completion of all pre-treatment evaluations. 10. 18 years or older.

Exclusion criteria

1. Previous pelvic RT. 2. Concurrent or previous malignancy 5 years prior to randomisation (except non-melanomatous skin cancer). 3. Androgen deprivation (AD) prior to or following RP. 4. Evidence of nodal or distant metastases. 5. Co-morbidities that would interfere with the completion of treatment or 5 years of follow-up. 6. Concurrent cytotoxic medication. 7. Hip prothesis

Outcome results