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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Julia Murray
+44 (0)20 8661 3458
julia.murray@icr.ac.uk


Ms Sandy Cheung
+44 (0)20 3437 6660
startrap-icrctsu@icr.ac.uk


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Be Part of Research - Trial Details - Using targeted radiotherapy to postpone the need to change treatment in men diagnosed with metastatic prostate cancer
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Using targeted radiotherapy to postpone the need to change treatment in men diagnosed with metastatic prostate cancer

Recruiting

Open to: Male

Age: Adult

Sutton London

Medical Conditions

Prostate cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The aim of this study is to test whether a precise radiotherapy technique called stereotactic body radiotherapy (SBRT) can delay the progression of cancer in two groups of metastatic prostate cancer (cancer that has spread). SBRT has been shown to be safe and effective in other groups of cancer patients who have a small number of metastases. The treatment is now widely available within the UK and researchers want to test if it is effective in patients with more advanced prostate cancer. Radiotherapy to the prostate can prolong survival time for patients with a small number of metastases at diagnosis. In metastatic lung cancer, there is evidence that using radiotherapy in areas that have not responded well to drug therapy significantly prolongs the time before more treatment is needed compared to those who did not receive radiotherapy. Some patients with advanced prostate cancer may also get this clinical benefit. Delaying the progression of cancer or being able to delay the next treatment may mean that patients have a better quality of life for longer. The researchers also want to understand how best to manage patients who become resistant to initial drug treatment. They will use this knowledge to recommend SBRT to patients with a few (<5) metastases. They will also look for links between imaging findings and outcomes to see if these findings predict which patients benefit most from the addition of SBRT.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

19 Dec 2024 18 Dec 2026

Patients in both abovementioned groups will be randomly allocated to either:
1. Continue first-line systemic therapy, which is to continue the treatment they are already having at the point of trial entry
2. Continue first-line systemic therapy and SBRT to metastases +/- prostate radiotherapy
The radiotherapy will be delivered to all metastases and/or prostate. The radiotherapy will be delivered in 3-5 appointments to the metastases and 5 appointments to the prostate over 2 weeks. The appointments to the metastases and prostate will be done simultaneously.
For induced oligometastatic disease participants are required to have a PSMA PET-CT scan to determine their eligibility. An MRI scan may also be performed with optional consent. All participants will be asked to complete questionnaires to examine any side effects of treatment and review the impact on quality of life. PSA tests and imaging will be conducted by sites to monitor how well the treatment has worked.


This study will recruit participants in two different groups of metastatic prostate cancer. They will either:
1. Have on PSMA PET-CT scans an excellent response with 5 or fewer active sites (induced oligometastatic disease) after 6-12 months of systemic therapy
2. Be on first-line systemic therapy with evidence of an increase in PSA and on imaging have 5 or fewer active sites on scans (oligoprogression)

You can take part if:



You may not be able to take part if:


1. Prior radiotherapy at or near a metastatic site to be treated in STAR-TRAP that precludes the safe delivery of SBRT. Patients that have received prior SBRT to the prostate for localised prostate cancer treatment are permitted, but the patients will not be suitable to receive SBRT to the prostate in STAR-TRAP2. Comorbidities precluding staging or follow-up imaging, or precluding procedures required to facilitate SBRT3. Any single metastasis >6 cm (>5 cm for lung metastases)4. Spinal cord compression, or impingement of the cord or any other situation whereby the clinician feels that urgent radiotherapy to the spine is required (within 24 hours). Patients are allowed to enter STAR-TRAP if they have a previous history of SCC, providing other eligibility criteria are met.5. Any condition or significant clinical co-morbidities which would precludes the safe delivery of SBRT to any sites of metastatic disease and prostate (if applicable). A non-exhaustive list is provided below and research teams at site should consult this when assessing patient suitability for SBRT prior to randomisation:5.1. A history of clinically significant diffuse interstitial lung disease or radiological evidence of idiopathic pulmonary fibrosis if SBRT to lung metastases or lesions adjacent to lungs are considered5.2. Clinically significant colitis i.e. ulcerative colitis /Crohn’s disease if SBRT to the pelvis or abdomen is considered6. Any active malignancies (i.e., progressing or requiring any treatment in the previous 36 months) other than prostate cancer (except non-muscle invasive bladder cancer; non-melanomatous skin cancer, small renal masses or a malignancy that is considered cured with minimal risk of recurrence)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Marsden Hospital (surrey)
    Downs Road
    Sutton
    SM2 5PT
  • The Royal Marsden Hospital (london)
    Fulham Road
    London
    SW3 6JJ

There is no guarantee that participants will benefit directly from taking part in this study. The aim is to find out whether SBRT can delay the progression of cancer in metastatic prostate cancer patients. We do not currently know whether this is the case. The information from this study may help in treating people with cancer in the future. Participants may experience side effects from the study treatment. The effects of the SBRT treatment are not completely known.

Ms Sandy Cheung
+44 (0)20 3437 6660
startrap-icrctsu@icr.ac.uk


Dr Julia Murray
+44 (0)20 8661 3458
julia.murray@icr.ac.uk



The study is sponsored by Institute of Cancer Research and funded by Prostate Cancer UK; Grant Codes: RIA21-ST2-015.




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Read full details for Trial ID: ISRCTN16448082

Or CPMS 59115

Last updated 19 February 2025

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