Evaluating the efficacy of radiation therapy compared to surveillance in men with prostate cancer that has returned after surgery and negative Prostate specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) scan.

Not Applicable

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12622001478707
• Lead Sponsor: The Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-24
• Last Update Posted: 5 December 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. Previous prostate cancer diagnosis treated with radical prostatectomy
2. Post-prostatectomy biochemical recurrence (Prostate-specific antigen (PSA) 0.2 - 0.5 nanograms per milliliter) with documented 2 consecutive PSA rises taken at least 14 days apart
3. Low risk features (Gleason score less than equal to 3 plus 4 / ISUP grade group less than equal to 2 and PSA doubling time greater than 12 months)
4. Willing to complete study requirements (treatments, questionnaires etc.)
5. ECOG performance status 0 or 1
6. Estimated life expectancy greater than 7yrs
7. Prior PSMA PET/CT for investigation of early biochemical recurrence
8. Prior pelvic radiation therapy that would impact delivery of the protocol radiotherapy

Exclusion Criteria

1. Contraindications to radiotherapy (e.g., active inflammatory bowel disease)
2. Prior or current androgen deprivation therapy (ADT) or other systemic therapy for prostate cancer
3. Bilateral orchidectomy
4. Positive regional nodal disease (N1 positive) at radical prostatectomy
5. Evidence of metastatic disease on any imaging modality
6. History of another malignancy within 5 years prior to randomisation except for those listed
7. Concurrent illness that might jeopardise the ability to undergo study procedures
8. Participation in other clinical trials of investigational agents for treatment of prostate cancer or other diseases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event free survival<br> <br>[6 months post-randomisation, then 6 monthly for a minimum of 3 years post-randomisation or until study end.]