A multi-centre, randomised phase 2 clinical trial of early salvage radiotherapy versus surveillance on the incidence of biochemical recurrence after radical prostatectomy for men with prostate cancer, incorporating clinical and imaging-based risk stratification.

The Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd0 个研究点目标入组 100 人开始时间: 2022年11月24日最近更新: 2022年12月5日

适应症

试验速览

暂无简介。

•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

•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

发起方

The Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd