Prostate cancer Cancer
Conditions
Interventions
The method of randomisation is 1:1 allocation ratio using minimisation with a random element. The two cohorts will have separate minimisation algorithms.
Participants in the induced oligo-metastatic
Sponsors
Institute of Cancer Research
Eligibility
Sex/Gender
Male
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the prostate 2. Aged >=18 years 3. On ADT + ARPI (abiraterone, enzalutamide, apalutamide, darolutamide) +/- docetaxel 4. WHO performance status 0 to 2 5. Written informed consent Additional cohort-specific eligibility: Induced oligometastatic cohort Registration part: 1. Metastatic hormone-sensitive prostate cancer, poly-metastatic at diagnosis (>5 metastases) confirmed on any imaging modality. 2. Receiving ADT + first-line systemic therapy (ARPI +/- docetaxel). 3. 5-12 months since initiating ADT (including LHRH agonists/antagonists and bicalutamide). 4. PSA = 25% and >= 2 ng/ml above the nadir) OR a PSA increase of >= 25% above the nadir if PSA was = 3 weeks later.
Exclusion criteria
Exclusion criteria: 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-TRAP 2. Comorbidities precluding staging or follow-up imaging, or precluding procedures required to facilitate SBRT 3. 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 considered 5.2. Clinically significant colitis i.e. ulcerative colitis /Crohn’s disease if SBRT to the pelvis or abdomen is considered 6. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Induced oligometastatic cohort: Failure-free survival, defined as the time from randomisation to first biochemical failure (PSA value); new, radiological progression; or prostate cancer death. PSA values and imaging will be data collected throughout the trial. These assessments will be conducted as per sites’ standard of care intervals. Oligoprogressive cohort: Time to discontinuation of first-line therapy, defined as the time from randomisation to time the patient discontinues their first-line therapy where the reason for stopping is related to progression and if a patient were to commence a new treatment for their prostate cancer it would need to be a second line therapy or related to palliative care. This will be collected throughout the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to discontinuation of first-line therapy (induced oligometastatic cohort) - this is defined as the time from randomisation to time the patient discontinues their first-line therapy where the reason for stopping is related to progression and if a patient were to commence a new treatment for their prostate cancer it would need to be a second line therapy or related to palliative care. This will be collected throughout the trial. 2. Time to second-line systemic therapy – this is defined as the time from randomisation to the time the patient starts second-line systemic therapy. If a patient doesn’t start a second-line therapy but stops first-line the date the patient stops their first-line therapy will be used instead. This will be collected throughout the trial. 3. Radiological progression-free survival – this is defined as the time from randomisation to radiographic progression or death from any cause. Imaging will be conducted as per sites’ standard of care intervals. Imaging data will be collected throughout the trial. 4. Overall survival is defined as the time from randomisation to death from any cause. Survival status and cause of death will be collected throughout the trial. 5. Time to second progression-free survival – this is defined as the time from randomisation to first clinician-determined disease progression (PSA progression, radiographic progression, clinical progression or death from any cause) after patients stop their first-line therapy. PSA values and imaging will be data collected throughout the trial. These assessments will be conducted as per sites’ standard of care intervals. 6. Patient-reported outcomes will be collected using the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) and EQ5D-5L to report the frequency of each PRO-CTCAE. Patient-reported outcomes questionnaire will be collected at screening, end of SBRT (or equivalent timepoint for SOC arm), 12 weeks from the start of SBRT (or | — |
Countries
England, United Kingdom
Outcome results
None listed