Prostate CancerTRAPNCT03644303
Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients.
A study testing SBRT + ADT in people with Prostate Cancer and Metastasis, run by Royal Marsden NHS Foundation Trust at 7 sites in United Kingdom.
Trial summary
This multi-center, phase II trial will be conducted in men with castration resistant prostate cancer. The aim of the TRAP trial is to test whether a new precise radiotherapy technique called stereotactic body radiotherapy (SBRT) can slow down the growth of metastatic prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Metastasis, Toxicity Due to Radiotherapy
- What is being tested?
- SBRT + ADT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 13 Aug 2018to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide written informed consent for the trial and be ≥18 years of age on day of signing informed consent.
- Have metastatic Castration Resistant Prostate Cancer (CRPC) based on biochemical or pathological diagnosis and be on Enzalutamide or Abiraterone.
- Have had a minimum of 6 months on Enzalutamide or Abiraterone with evidence of response (PSA, radiological or symptomatic)
- Have 1 - 2 metastatic lesions progressing on imaging (CT, bone scan, MRI or other local imaging) or a clinical or imaging diagnosis of progression of a non-irradiated primary site with the remainder of their metastases currently controlled by Enzalutamide or Abiraterone.
- Have had no previous radical radiation to the index area (defined as unable to deliver SBRT doses in this protocol without taking normal tissues beyond tolerance).
- Have a Performance Status (PS) assessed using the Eastern Co-operative Oncology Group (ECOG) criteria of 0 - 1.
- Have an oligoprogressing site, including those that have developed on treatment, in bone, lymph node, prostate or lung but not in liver, brain, adrenal or other sites.
- Patients may be symptomatic in the oligoprogressing area. However, there is no urgent need to start radiotherapy.
Who cannot join
- A clinical need exists to switch therapy immediately (e.g. suspicion of rapid clinical progression, urgent need for palliative radiotherapy).
- Evidence of previous invasive cancer in the last 5 years, with the exception of non-melanoma skin cancer (non-invasive malignancies such as non-muscle invasive bladder cancer are not excluded).
- There is a contra-indication to radiotherapy (e.g. inflammatory bowel disease).
- There is a contra-indication to MRI where required for radiotherapy (e.g. cardiac pacemaker, internal defibrillator, shrapnel injury or claustrophobia).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Belfast Health & Social care Trust
Belfast, Northern Ireland, BT8 8BH
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2TH
Velindre Cancer Centre
Cardiff, Wales, CF14 2TL
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS9 7TF
The Christie NHS Foundation Trust
Manchester, Manchester Greater, M20 4BX
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Angelie Tirona
Sutton, Surrey, SM5 3EZ
About this study
Official title: TRAP - Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients.
This multi-center, phase II trial will be conducted in men with castration resistant prostate cancer. The aim of the TRAP trial is to test whether a new precise radiotherapy technique called stereotactic body radiotherapy (SBRT) can slow down the growth of metastatic prostate cancer. If SBRT is effective it will represent a new treatment option in these patients, providing more prolonged control without having to resort to chemotherapy and its potentially unpleasant side effects.
In this trial, the investigators will identify men who, despite being on next generation androgen deprivation treatment (Abiraterone or Enzalutamide) have developed one or two new sites of worsening (growing) disease but the rest of their cancer is still responding to hormonal therapy. If it is the case that SBRT can successfully treat the cancer which is resistant to current treatment then the investigators hope they will be able to better control the spread of cancer in these patients for longer.
The investigators also hope that they will be able to use the tell-tale products (gene markers) that are released into the bloodstream in these patients, or identify characteristics on novel imaging such as magnetic resonance imaging (MRI) to help identify patients in the future who will benefit the most.
Read the detailed description
For many men with metastatic prostate cancer, the cancer develops resistance to successive systemic therapies and eventually all treatment options are exhausted and the patient succumbs to their disease. It is therefore vital to find ways of evading prostate cancer resistance. Stereotactic body radiotherapy (SBRT) has the advantage that it destroys cancerous tissue irrespective of the underlying genetic deficit within the progressing metastasis. If the resistant clones are localized to 1-2 metastases and can be destroyed or ablated, the patient can continue to receive the benefit of their systemic (androgen deprivation) treatment (Abiraterone or Enzalutamide) which may continue to control the remainder of their disease for many months, possibly even years.
SBRT is a recognised technique for the elimination of isolated metastases in other tumour sites achieving local control of metastasis in 80-90% of cases. This is achieved with very few side effects. In the TRAP trial, the investigators wish to establish whether it is beneficial to target 1 or 2 metastatic sites with SBRT or whether patients will develop polymetastatic progression. Patients enrolled on the trial will receive 30 Gy in 5 fractions on alternate days over 10 days. They will continue their androgen deprivation treatment throughout and following SBRT. Side effects will be closely monitored throughout and patients will be seen at the end of radiotherapy and then 4 weeks after treatment. Thereafter patients will undergo trial follow up three monthly which will includes Prostate Specific Antigen (PSA) monitoring.
In addition to the above procedures, the investigators will use a combination of whole body (WB) diffusion weighted (DW) magnetic resonance imaging (WB DW MRI) and circulating tumour (ct) deoxyribonucleic acid (DNA), 'ct DNA' biomarker analysis with the aim of identifying those patients which benefit most from the combination of SBRT and androgen deprivation treatment. WB DW MRI is a novel MRI technique which shows improved sensitivity compared to standard MRI. The marker ctDNA enables the investigators to explore genomic characterisation and variation of metastases and compare findings with previously explored genome mutations in prostate cancer patients.
- Being tested
- SBRT + ADT
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT + ADTRadiation
Also called Enzalutamide or Abiraterone plus stereotactic radiotherapy
Short course SBRT to 1 or 2 oligo-progressing metastases in addition to continued abiraterone or enzalutamide
| Study group | Role | What they receive |
|---|---|---|
| SBRT + ADT | Experimental | Enzalutamide OR Abiraterone at licensed doses in combination with stereotactic radiotherapy: 30 Gray in 5 fractions Receives: Radiation: SBRT + ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression-Free Survival (PFS)
Median progression free survival following SBRT to progression, starting new treatment or death from any cause.
Progression is defined as one of the following; (i) PSA progression: PSA rise by at least 25% over post-SBRT baseline (set at 4 weeks), confirmed by a second reading at least 4 weeks later, (ii) Radiological progression: at least 2 new lesions on bone scan or unequivocal progression of soft tissue on CT, or evidence on other local imaging of disease progression (e.g. PET or MRI progression) as per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) (iii) Symptomatic progression: new or progressing symptoms at the site of a metastasis, or (iv) Date at which the clinician decides to stop Abiraterone/Enzalutamide or starts new line of therapy, whichever occurs sooner.
Measured: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Secondary outcomes (13)
Progression-Free Survival (PFS) Events
Number of patients that had a PFS event following SBRT in the duration of the study. Progression free survival definition is time from SBRT to progression, starting new treatment or death from any cause.
Progression is defined as one of the following; (i) PSA progression: PSA rise by at least 25% over post-SBRT baseline (set at 4 weeks), confirmed by a second reading at least 4 weeks later, (ii) Radiological progression: at least 2 new lesions on bone scan or unequivocal progression of soft tissue on CT, or evidence on other local imaging of disease progression (e.g. PET or MRI progression) as per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) (iii) Symptomatic progression: new or progressing symptoms at the site of a metastasis, or (iv) Date at which the clinician decides to stop Abiraterone/Enzalutamide or starts new line of therapy, whichever occurs sooner.
Measured: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Progression-Free Survival (PFS) Estimates
Progression free survival estimates following SBRT to progression, starting new treatment or death from any cause.
Progression is defined as one of the following; (i) PSA progression: PSA rise by at least 25% over post-SBRT baseline (set at 4 weeks), confirmed by a second reading at least 4 weeks later, (ii) Radiological progression: at least 2 new lesions on bone scan or unequivocal progression of soft tissue on CT, or evidence on other local imaging of disease progression (e.g. PET or MRI progression) as per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) (iii) Symptomatic progression: new or progressing symptoms at the site of a metastasis, or (iv) Date at which the clinician decides to stop Abiraterone/Enzalutamide or starts new line of therapy, whichever occurs sooner.
Measured: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Local Control Rate Following SBRT
Overall control defined as stable disease or partial response of irradiated metastases assessed using the RECIST (v 1.1) criteria on imaging such as computed Tomography (CT), magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scan or control on bone scan
Measured: At the 6 month timepoint from end of SBRT
Median Overall Survival (OS)
Median OS following SBRT until death from any cause.
Measured: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Overall Survival (OS) Events
Number of patients who had an OS event following SBRT in the duration of the study. Overall survival definition is time from SBRT to death from any cause.
Measured: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Overall Survival (OS) Estimates
OS estimates following SBRT to death from any cause.
Measured: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Median Time to Administration of Next Line of Therapy or Death
Median time following SBRT to alternative therapy administration or death.
Measured: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Administration of Next Line of Therapy or Death Events
Number of patients that started new treatment or died following SBRT in the duration of the study.
Measured: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Time to Administration of Next Line of Therapy or Death
Time estimates from SBRT to alternative therapy administration or death.
Measured: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Health Related Quality of Life
Patient Reported Quality of Life assessed using the EuroQol (EQ) EQ-5D-5L questionnaire. VAS scale is from 0-100. A higher VAS score indicates better quality-of-life. Outcome data has been reported for (i) all completed assessments and for (ii) assessments conducted up to the point of disease progression, in order to exclude the potential influence of progression on quality-of-life outcomes.
Measured: Up to 12 months from the end of SBRT
Number of Participants With Incidence and Severity of Treatment Induced Symptoms (RTOG)
Severity of acute and late side-effects resulting from SBRT assessed using the RTOG (Radiation Therapy Oncology Group) scoring criteria. A higher RTOG grade suggests higher severity of symptoms. Overall maximum grade for each patient at each timepoint is reported.
Measured: Up to 24 months from the end of SBRT
Number of Participants With Incidence and Severity of Treatment Induced Symptoms (CTCAE)
Severity of acute and late side-effects resulting from SBRT assessed using the Common Terminology Criteria for Adverse Events (CTCAE). A higher CTCAE grade suggests higher severity of symptoms. Overall maximum grade for each patient at each timepoint is reported.
Measured: Up to 24 months from the end of SBRT
Prostate Specific Antigen (PSA) Values
Prostate Specific Antigen (PSA) values recorded post-SBRT
Measured: Up to 12 months from the end of SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start13 Aug 2018
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, prospective interventional cohort study
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer UK, University College, London, The Christie NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Velindre NHS Trust, University Hospital Birmingham NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Belfast Health and Social Care Trust
- Responsible party
- Sponsor
- Investigators
- Alison Tree, FRCR, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644303
- Sponsor's protocol ID
- CCR 4781
- Acronym
- TRAP
- Status last verified
- Apr 2026
- First submitted
- 15 Aug 2018
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Human tissue (blood) in surplus will be made available for other ethically approved research provided patients have given their informed consent
Publications
Lee J, Koom WS, Byun HK, Yang G, Kim MS, Park EJ, Ahn JB, Beom SH, Kim HS, Shin SJ, Kim K, Chang JS. Metastasis-Directed Radiotherapy for Oligoprogressive or Oligopersistent Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2022 Jun;21(2):e78-e86. doi: 10.1016/j.clcc.2021.10.009. Epub 2021 Nov 18.
PubMed 34903471
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRAP - Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients.
- ClinicalTrials.gov ID
- NCT03644303
- Acronym / sponsor ID
- TRAP / CCR 4781
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Prostate Cancer UK, University College, London, The Christie NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Velindre NHS Trust, University Hospital Birmingham NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Belfast Health and Social Care Trust
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center, phase II trial will be conducted in men with castration resistant prostate cancer. The aim of the TRAP trial is to test whether a new precise radiotherapy technique called stereotactic body radiotherapy (SBRT) can slow down the growth of metastatic prostate cancer. If SBRT is effective it will represent a new treatment option in these patients, providing more prolonged control without having to resort to chemotherapy and its potentially unpleasant side effects.
In this trial, the investigators will identify men who, despite being on next generation androgen deprivation treatment (Abiraterone or Enzalutamide) have developed one or two new sites of worsening (growing) disease but the rest of their cancer is still responding to hormonal therapy. If it is the case that SBRT can successfully treat the cancer which is resistant to current treatment then the investigators hope they will be able to better control the spread of cancer in these patients for longer.
The investigators also hope that they will be able to use the tell-tale products (gene markers) that are released into the bloodstream in these patients, or identify characteristics on novel imaging such as magnetic resonance imaging (MRI) to help identify patients in the future who will benefit the most.
Detailed description
For many men with metastatic prostate cancer, the cancer develops resistance to successive systemic therapies and eventually all treatment options are exhausted and the patient succumbs to their disease. It is therefore vital to find ways of evading prostate cancer resistance. Stereotactic body radiotherapy (SBRT) has the advantage that it destroys cancerous tissue irrespective of the underlying genetic deficit within the progressing metastasis. If the resistant clones are localized to 1-2 metastases and can be destroyed or ablated, the patient can continue to receive the benefit of their systemic (androgen deprivation) treatment (Abiraterone or Enzalutamide) which may continue to control the remainder of their disease for many months, possibly even years.
SBRT is a recognised technique for the elimination of isolated metastases in other tumour sites achieving local control of metastasis in 80-90% of cases. This is achieved with very few side effects. In the TRAP trial, the investigators wish to establish whether it is beneficial to target 1 or 2 metastatic sites with SBRT or whether patients will develop polymetastatic progression. Patients enrolled on the trial will receive 30 Gy in 5 fractions on alternate days over 10 days. They will continue their androgen deprivation treatment throughout and following SBRT. Side effects will be closely monitored throughout and patients will be seen at the end of radiotherapy and then 4 weeks after treatment. Thereafter patients will undergo trial follow up three monthly which will includes Prostate Specific Antigen (PSA) monitoring.
In addition to the above procedures, the investigators will use a combination of whole body (WB) diffusion weighted (DW) magnetic resonance imaging (WB DW MRI) and circulating tumour (ct) deoxyribonucleic acid (DNA), 'ct DNA' biomarker analysis with the aim of identifying those patients which benefit most from the combination of SBRT and androgen deprivation treatment. WB DW MRI is a novel MRI technique which shows improved sensitivity compared to standard MRI. The marker ctDNA enables the investigators to explore genomic characterisation and variation of metastases and compare findings with previously explored genome mutations in prostate cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, prospective interventional cohort study
| Arm | Type | Receives |
|---|---|---|
| SBRT + ADT | Experimental | Radiation: SBRT + ADTEnzalutamide OR Abiraterone at licensed doses in combination with stereotactic radiotherapy: 30 Gray in 5 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be willing and able to provide written informed consent for the trial and be ≥18 years of age on day of signing informed consent.
- Have metastatic Castration Resistant Prostate Cancer (CRPC) based on biochemical or pathological diagnosis and be on Enzalutamide or Abiraterone.
- Have had a minimum of 6 months on Enzalutamide or Abiraterone with evidence of response (PSA, radiological or symptomatic)
- Have 1 - 2 metastatic lesions progressing on imaging (CT, bone scan, MRI or other local imaging) or a clinical or imaging diagnosis of progression of a non-irradiated primary site with the remainder of their metastases currently controlled by Enzalutamide or Abiraterone.
- Have had no previous radical radiation to the index area (defined as unable to deliver SBRT doses in this protocol without taking normal tissues beyond tolerance).
Key exclusion criteria (4 listed)
- A clinical need exists to switch therapy immediately (e.g. suspicion of rapid clinical progression, urgent need for palliative radiotherapy).
- Evidence of previous invasive cancer in the last 5 years, with the exception of non-melanoma skin cancer (non-invasive malignancies such as non-muscle invasive bladder cancer are not excluded).
- There is a contra-indication to radiotherapy (e.g. inflammatory bowel disease).
- There is a contra-indication to MRI where required for radiotherapy (e.g. cardiac pacemaker, internal defibrillator, shrapnel injury or claustrophobia).
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 |
|---|---|---|
| SBRT + ADTAlso: Enzalutamide or Abiraterone plus stereotactic radiotherapyShort course SBRT to 1 or 2 oligo-progressing metastases in addition to continued abiraterone or enzalutamide | Radiation | SBRT + ADT |
Primary outcome
Median Progression-Free Survival (PFS)
Time frame: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Median progression free survival following SBRT to progression, starting new treatment or death from any cause. Progression is defined as one of the following; (i) PSA progression: PSA rise by at least 25% over post-SBRT baseline (set at 4 weeks), confirmed by a second reading at least 4 weeks later, (ii) Radiological progression: at least 2 new lesions on bone scan or unequivocal progression of soft tissue on CT, or evidence on other local imaging of disease progression (e.g. PET or MRI progression) as per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) (iii) Symptomatic progression: new or progressing symptoms at the site of a metastasis, or (iv) Date at which the clinician decides to stop Abiraterone/Enzalutamide or starts new line of therapy, whichever occurs sooner.
13 secondary outcomes
Progression-Free Survival (PFS) Events
Time frame: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Progression-Free Survival (PFS) Estimates
Time frame: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Local Control Rate Following SBRT
Time frame: At the 6 month timepoint from end of SBRT
Median Overall Survival (OS)
Time frame: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Overall Survival (OS) Events
Time frame: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Overall Survival (OS) Estimates
Time frame: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Median Time to Administration of Next Line of Therapy or Death
Time frame: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Administration of Next Line of Therapy or Death Events
Time frame: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Time to Administration of Next Line of Therapy or Death
Time frame: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Health Related Quality of Life
Time frame: Up to 12 months from the end of SBRT
Number of Participants With Incidence and Severity of Treatment Induced Symptoms (RTOG)
Time frame: Up to 24 months from the end of SBRT
Number of Participants With Incidence and Severity of Treatment Induced Symptoms (CTCAE)
Time frame: Up to 24 months from the end of SBRT
Prostate Specific Antigen (PSA) Values
Time frame: Up to 12 months from the end of SBRT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34903471Lee J, Koom WS, Byun HK, Yang G, Kim MS, Park EJ, Ahn JB, Beom SH, Kim HS, Shin SJ, Kim K, Chang JS. Metastasis-Directed Radiotherapy for Oligoprogressive or Oligopersistent Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2022 Jun;21(2):e78-e86. doi: 10.1016/j.clcc.2021.10.009. Epub 2021 Nov 18.
- Individual participant dataSharing planned: Yes. Human tissue (blood) in surplus will be made available for other ethically approved research provided patients have given their informed consent
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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. This study is not recruiting at the moment.
Alison Tree, FRCR principal investigator
Royal Marsden NHS Foundation Trust
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT + ADT in people with Prostate Cancer and Metastasis, run by Royal Marsden NHS Foundation Trust at 7 sites in United Kingdom.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Progression-Free Survival (PFS) (time frame: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644303, which also lists 1 linked publication.
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 14 May 2026.