Prostate cancer Cancer
Conditions
Interventions
Current interventions as of 30/06/2025:
All patients will undergo WBMRI prior to commencement of systemic treatment and again at 8-12 weeks with target of 8-9 weeks from start of treatment to align
Sponsors
Institute of Cancer Research
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 30/06/2025: 1. Age = 18 years. 2. Metastatic castration-resistant prostate cancer with bone-predominant disease confirmed on bone scan, CT, or limited (pelvic) MRI performed within 8 weeks prior to trial entry (bone-predominant disease confirmed on the CT component of PET-CT is permissible). Or for patients who have already had a WBMRI performed within 6 weeks of starting therapy and are to be enrolled onto the trial after they have started treatment: bone -predominant disease confirmed on bone scan, CT, or limited (pelvic) MRI performed within 8 weeks prior to start of treatment (bone-predominant disease confirmed on the CT component of PET-CT is permissible). 2.3. Systemic therapy (any line) clinically indicated and planned (or already started*) for treatment of disease progression, as defined and confirmed locally with potential definitions including but not limited to: • Progression on bone scan: = 2 new documented bone lesions over the previous 6 months • AND/OR increasing PSA level: 2 consecutive increases in PSA level documented over a previous reference value obtained at least one week apart. If the third PSA value is less than the second, an additional fourth test to confirm the rising PSA is required. 3.4. Willing and able to comply with the protocol defined imaging assessments. 4.5. Fully informed about the study and provided written informed consent. * For patient who have already had a WBMRI as part of their routine care within 6 weeks of starting therapy and are to be enrolled into the trial after they have started treatment prior to the protocol-defined 8-12 week scan. _____ Previous inclusion criteria: 1. Age > = 18 years. 2. Metastatic castration-resistant prostate cancer with bone-predominant disease confirmed on bone scan, CT, or limited (pelvic) MRI performed within 8 weeks prior to trial entry (bone-predominant disease confirmed on the CT component of PET-CT is permissible). 3. Systemic therapy (any line) clinically indicated and planned for the treatment of disease progression, as defined and confirmed locally with potential definitions including but not limited to: 3.1. Progression on a bone scan: > = 2 new documented bone lesions over the previous 6 months 3.2. AND/OR increasing PSA level: 2 consecutive increases in PSA level documented over a previous reference value obtained at least one week apart. If the third PSA value is less than the second, an additional fourth test to confirm the rising PSA is required. 4. Willing and able to comply with the protocol-defined imaging assessments. 5. Fully informed about the study and provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Unsuitable for WBMRI (patient refusal and/or contraindicated) 2. Patients with RECIST-measurable disease 3. Any radiotherapy within 8 weeks prior to trial entry (chemotherapy or other anti-cancer therapy are permissible).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 30/06/2025: 1. The proportion of patients with evidence of radiological progression as assessed using the 8-12 weeks WBMRI after start of treatment supported with software reporting. _____ Previous primary outcome measure: 1. Number of patients with evidence of radiological progression as assessed in the first on-treatment imaging performed at 8-9 weeks after start of treatment. 2. Number of patients for whom decision is made to discontinue treatment due to disease progression following the first on-treatment imaging (8-9 weeks) and before start of subsequent cycle, taking into account imaging and all other available evidence. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 30/06/2025: 1. Proportion of patients with radiological response using the 8-12 weeks WBMRI with software reporting. 2. Proportion of patients for whom decision is made to discontinue treatment due to disease progression following the 8-12 week WBMRI with software reporting, taking into account imaging and all other available evidence. 3. Clinician’s confidence in clinical decision making (continue/discontinue treatment) following the 8-12 weeks WBMRI with software reporting. 4. Proportion of patients who respond to treatment according to the clinician perspective following the 8-12 week WBMRI scan. 5. Time to treatment discontinuation and reason(s) for treatment discontinuation. 6. Radiological progression free survival (rPFS), progression free survival (PFS) 7. Association between time to radiological progression and time to PSA progression. _____ Previous secondary outcome measures: 1. Clinician’s confidence in clinical decision making (continue/discontinue treatment) after first on-treatment scan (8-9 weeks from start of therapy). 2. Proportion of patients who respond to treatment according to clinician perspective at the first on-treatment imaging (8-9 weeks from start of treatment) 3. Time to treatment discontinuation and the specific reason(s) a therapy was ultimately discontinued measured using patient records 4. Health-related quality of life (using EQ-5D-5L) at baseline, at first on-treatment scan (8-9 weeks) and 12 months from start of treatment. 5. Overall survival at 12 months measured using patient records 6. Radiological Progression Free Survival (rPFS) and Progression Free Survival (PFS) measured using patient records 7. Time to radiological progression and time to PSA progression measured using patient records 8. In the WBMRI group, proportion of patients with radiological response measured using patient records 9. Health economic evaluation with budget impact and cost-effectiveness of WBMRI | — |
Countries
United Kingdom
Outcome results
None listed