Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Luteinising Hormone-Releasing Factor Analogue | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- No androgen deprivation
- description
- Those patients not given androgen deprivation therapy
- label
- Short course androgen deprivation
- description
- Those patients given 6 months of androgen deprivation therapy
- interventionNames
- Drug: Luteinising Hormone-Releasing Factor Analogue
- label
- Long course androgen deprivation
- description
- Those patients given 24 months of androgen deprivation therapy
- interventionNames
- Drug: Luteinising Hormone-Releasing Factor Analogue
Primary outcomes (1)
- measure
- Freedom from Distant Metastases
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available