Status:
NOT_YET_RECRUITING
Radiotherapy and Androgen Deprivation In Combination After Local Surgery (RADICALS) Translational Study
Lead Sponsor:
University College, London
Conditions:
Prostate Cancer
Eligibility:
MALE
18-99 years
Brief Summary
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...
Detailed Description
Early prostate cancer represents a wide spectrum of disease. Indolent disease is unlikely to ever become symptomatic and treatment is needlessly morbid and costly. Aggressive disease warrants intensif...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2028
Estimated Enrollment :
2585 Patients enrolled
Trial Details
Trial ID
NCT06145958
Start Date
January 1 2024
End Date
August 30 2028
Last Update
November 24 2023
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