Radiotherapy following radical prostatectomy - Adjuvant Versus Early Salvage

Phase 3

Completed

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12611000781943
• Lead Sponsor: Trans Tasman Radiation Oncology Group (TROG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-26
• Study Completion: 2022-12-31
• Last Update Posted: 12 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 333

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biochemical failure: PSA >=0.4ng/ml and rising following RT. PSA will be measured through blood tests.[After 160 events have been observed, expected to be 5 years after the end of accrual.<br>Arm 1, Adjuvant Radiotherapy - 6 weeks post RT, then 6 monthly until the end of trial<br>Arm 2, Surveillance - every three months from randomisation for the first 5 years, then 6 monthly thereafter until rising PSA]