STAR-TRAP
Research type
Research Study
Full title
Randomised phase II clinical trial of using stereotactic body radiotherapy (SBRT) on first-line androgen receptor pathway inhibitor for metastatic prostate cancer
IRAS ID
334445
Contact name
Julia Murray
Contact email
Sponsor organisation
The Institute of Cancer Research
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
STAR-TRAP will look at whether a precise radiotherapy technique called stereotactic body radiotherapy (SBRT) can delay progression of cancer in two groups of metastatic prostate cancer patients.
The two groups of patients are those:
1) whose cancer is responding well to first line hormone treatment and now have five or fewer visible metastases (cancer which has spread beyond the prostate) using the most sensitive imaging techniques available including PSMA PET-CT scans and whole-body MRI scans.
2) on first line hormone therapy but there is evidence on the blood tests that the hormone therapy has stopped being effective, with imaging showing activity in up to 5 sites with the rest of their cancer still responding to hormonal therapy.Patients in both groups will be randomly assigned to either:
a) continue on the first line systemic therapy, which is the treatment they would receive if they were not in the trial.
b) continue on first line systemic therapy with SBRTSTAR-TRAP will recruit 236 participants at NHS radiotherapy centres in the UK that are experienced in giving SBRT. The radiotherapy will be delivered to all metastases and/or prostate. The radiotherapy will be delivered in 3-5 appointments over 2 weeks. Participants will be followed for 36 months from the date of random assignment.
For both groups, if radiotherapy is effective this will be a new management strategy in these patient groups, meaning existing medicines can control the cancer for longer.
REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0335
Date of REC Opinion
11 Jul 2024
REC opinion
Further Information Favourable Opinion