Radiotherapy and Androgen Deprivation In Combination After Local Surgery (RADICALS) Translational Study
- Conditions
- Prostate Cancer
- Interventions
- Drug: Luteinising Hormone-Releasing Factor Analogue
- Registration Number
- NCT06145958
- Lead Sponsor
- University College, London
- 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:
• 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.
- 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 intensification of therapy. Current clinical methods are poor at discriminating these outcomes.
The RADICALS trial was the largest trial conducted to date in men requiring further curative treatment after an operation. It already defined the role for radiotherapy after surgery (prostatectomy). The standard of care is now for blood test (PSA) monitoring after prostatectomy with radiotherapy offered when the PSA rises. The role and duration of hormone treatment (androgen deprivation), given in combination with radiotherapy, remains less clear. Currently if androgen deprivation is to be given, the RADICALS data support the use of a 24-month course, but this entails a considerable burden of side-effects for patients. Pathological and biological markers are needed to identify those most likely to benefit from androgen deprivation.
In RADICALS-TR, the investigators will conduct translational analyses on the biopsy and prostatectomy specimens from the RADICALS trial. The investigators aim to identify prognostic features and biomarkers predictive of benefit from androgen therapy. The investigators will prioritise the refinement and validation of clinical biomarkers already close to clinical utilisation. In this way it is hoped that findings can rapidly translate to stratified clinical trials and improved patient care.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 2585
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Long course androgen deprivation Luteinising Hormone-Releasing Factor Analogue Those patients given 24 months of androgen deprivation therapy Short course androgen deprivation Luteinising Hormone-Releasing Factor Analogue Those patients given 6 months of androgen deprivation therapy
- Primary Outcome Measures
Name Time Method Freedom from Distant Metastases Up to 12 years The absence of prostate cancer metastases
- Secondary Outcome Measures
Name Time Method Freedom from treatment failure Up to 12 years Freedom from PSA progression whilst receiving androgen deprivation therapy
Clinical Progression Free survival Up to 12 years Clinical progression of prostate cancer or initiation of non-protocol hormone therapy or death from prostate cancer.
Non protocol hormone therapy Up to 12 years Initiation of hormone therapy other than that randomised.
Freedom from biochemical progression Up to 12 years Where a biochemical progression event is defined as a PSA level of ≥0.4ng/ml following radiotherapy or a PSA level of \> 2.0ng/ml regardless of prior radiotherapy.
Overall survival Up to 12 years Freedom from death from any cause
Disease Specific Survival Up to 12 years Freedom from prostate cancer specific death