Prostate CancerRADICALS-TRNCT06145958
Radiotherapy and Androgen Deprivation In Combination After Local Surgery (RADICALS) Translational Study
An observational study of Prostate Cancer, run by University College, London.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Luteinising Hormone-Releasing Factor Analogue
- How many people
- 2,585 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 30 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- Adult, Older adult
Study population: Patients were recruited to the RADICALS trial at one of two points: RT - after surgery for prostate cancer, possessing one or a number of higher risk features for subsequent relapse. These patients were randomised to either immediate radiotherapy or deferred until the point of biochemical relapse. HD - at the point of intiation of radiotherapy in the adjuvant or salvage setting. These patients were randomised to a number of different androgen deprivation durations (as detailed above in the cohort descriptions).
Who may be able to join
- 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
Who cannot join
- 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:
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Luteinising Hormone-Releasing Factor Analogue
- Keywords
- biomarker
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luteinising Hormone-Releasing Factor AnalogueDrug
Androgen Deprivation Therapy
| Study group | Role | What they receive |
|---|---|---|
| No androgen deprivation | Those patients not given androgen deprivation therapy | |
| Short course androgen deprivation | Those patients given 6 months of androgen deprivation therapy Receives: Drug: Luteinising Hormone-Releasing Factor Analogue | |
| Long course androgen deprivation | Those patients given 24 months of androgen deprivation therapy Receives: Drug: Luteinising Hormone-Releasing Factor Analogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Distant Metastases
The absence of prostate cancer metastases
Measured: Up to 12 years
Secondary outcomes (6)
Overall survival
Freedom from death from any cause
Measured: Up to 12 years
Disease Specific Survival
Freedom from prostate cancer specific death
Measured: Up to 12 years
Freedom from treatment failure
Freedom from PSA progression whilst receiving androgen deprivation therapy
Measured: Up to 12 years
Clinical Progression Free survival
Clinical progression of prostate cancer or initiation of non-protocol hormone therapy or death from prostate cancer.
Measured: Up to 12 years
Non protocol hormone therapy
Initiation of hormone therapy other than that randomised.
Measured: Up to 12 years
Freedom from biochemical progression
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.
Measured: Up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,585 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew W Fittall, BMBCh PhD, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145958
- Sponsor's protocol ID
- 159874
- Other IDs
- 329626
- Acronym
- RADICALS-TR
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On request - clinical outcome data is available from the RADICALS trial team.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06145958
- Acronym / sponsor ID
- RADICALS-TR / 159874
- Conditions
- Prostate Cancer
- Keywords
- biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,585 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No androgen deprivation | – | –Those patients not given androgen deprivation therapy |
| Short course androgen deprivation | – | Drug: Luteinising Hormone-Releasing Factor AnalogueThose patients given 6 months of androgen deprivation therapy |
| Long course androgen deprivation | – | Drug: Luteinising Hormone-Releasing Factor AnalogueThose patients given 24 months of androgen deprivation therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited to the RADICALS trial at one of two points: RT - after surgery for prostate cancer, possessing one or a number of higher risk features for subsequent relapse. These patients were randomised to either immediate radiotherapy or deferred until the point of biochemical relapse. HD - at the point of intiation of radiotherapy in the adjuvant or salvage setting. These patients were randomised to a number of different androgen deprivation durations (as detailed above in the cohort descriptions).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
- Consent has been given within the RADICALS (RT/HD) trial to translational research and follow up.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Luteinising Hormone-Releasing Factor AnalogueAndrogen Deprivation Therapy | Drug | Long course androgen deprivation, Short course androgen deprivation |
Primary outcome
Freedom from Distant Metastases
Time frame: Up to 12 years
The absence of prostate cancer metastases
6 secondary outcomes
Overall survival
Time frame: Up to 12 years
Disease Specific Survival
Time frame: Up to 12 years
Freedom from treatment failure
Time frame: Up to 12 years
Clinical Progression Free survival
Time frame: Up to 12 years
Non protocol hormone therapy
Time frame: Up to 12 years
Freedom from biochemical progression
Time frame: Up to 12 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No. On request - clinical outcome data is available from the RADICALS trial team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew W Fittall, BMBCh PhD principal investigator
UCL
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew W Fittall, BMBCh PhD (020 7679 6500, Matthew.Fittall@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Distant Metastases (time frame: Up to 12 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.