Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients. (NCT03644303) | Clinical Trial Compass
CompletedNot Applicable
Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients.
United Kingdom86 participantsStarted 2018-08-13
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Median Progression-Free Survival (PFS)
Timeframe: Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
. 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.
Exclusion criteria
. 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).