A Translational Study of Samples From the Radiotherapy and Androgen Deprivation In Combination After Local Surgery (RADICALS) Prostate Cancer Trial to Identify Those Most Likely to Benefit From Androgen Deprivation With Salvage Radiotherapy

159874

The goal of this translational study is to test the use of biomarkers in salvage treatment for prostate cancer after a previous operation to remove the prostate. The main question it aims to answer is: • Can a biomarker identify a group of patients most likely to benefit from androgen deprivation therapy in conjunction with salvage radiotherapy No new participants will be involved, but tumour samples will be acquired, for patients that gave their permission in the completed RADICALS RT and HD studies.

2024-01-01

2028-08-30

2028-08-30

Not yet recruiting

2585

DISEASE CHARACTERISTICS: Inclusion criteria: Diagnosis of nonmetastatic adenocarcinoma of the prostate Must have undergone radical prostatectomy Post-operative serum prostate-specific antigen (PSA) \< 0.4 ng/mL No post-operative biochemical failure, defined as EITHER two consecutive rises in PSA and final PSA \> 0.1 ng/mL OR three consecutive rises in PSA (for patients undergoing hormone therapy duration randomization) Exclusion criteria: Known distant metastases from prostate cancer PSA \> 5 ng/mL at the time of hormone randomization (for patients undergoing hormone therapy duration randomization) PATIENT CHARACTERISTICS: * No other active malignancy likely to interfere with protocol treatment or follow-up. * Consent has been given within the RADICALS (RT/HD) trial to translational research and follow up. PRIOR CONCURRENT THERAPY: Inclusion criteria: See Disease Characteristics Co-enrollment to other trials is permitted, providing this does not interfere with the outcome measures 5-α reductase inhibitors, soya, selenium, and vitamin E are acceptable non-trial therapies Exclusion criteria: Prior hormone therapy Bilateral orchidectomy Prior pelvic radiotherapy Neoadjuvant treatment Other concurrent therapies for prostate cancer (e.g., estrogens or cytotoxic chemotherapy) prior to disease progression

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The primary purpose of this study is to collect fixed tumour material in the previous RADICALS intervention trial. Cases are those receiving therapy vs controls receiving standard of care.'}, 'enrollmentInfo': {'count': 2585, 'type': 'ESTIMATED'}}

2023-11-24