NCT06145958Not yet recruiting
Radiotherapy and Androgen Deprivation In Combination After Local Surgery (RADICALS) Translational Study
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
Source: ClinicalTrials.gov · Last updated 24 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 2585 (estimated)
- First submitted
- 13 Nov 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 30 Aug 2028
- Lead sponsor
- University College, London
- Diseases
- Prostate cancer
- NCT number
- NCT06145958
What you commit to
- Study type: Observational
- Planned participants: 2585
- From 1 Jan 2024 to the primary completion date, 30 Aug 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Consent has been given within the RADICALS (RT/HD) trial to translational research and follow up.
- PRIOR CONCURRENT THERAPY:
- 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
Other illness
- Known distant metastases from prostate cancer PSA \> 5 ng/mL at the time of hormone randomization (for patients undergoing hormone therapy duration randomization)
- No other active malignancy likely to interfere with protocol treatment or follow-up.
Other
- PATIENT CHARACTERISTICS:
Who the study is looking for
- 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)
- 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
Criteria the registry did not label
- DISEASE CHARACTERISTICS:
Age in the registry: 18 years to 99 years · Sex: Male
This page is information, not medical advice. Discuss any trial with your doctor.