Prostate Cancer Clinical Trial
— MIDAS-ProstateOfficial title:
Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
NCT number | NCT05328505 |
Other study ID # | 22-5147 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 5, 2022 |
Est. completion date | August 2030 |
This is a Phase II prospective sing-arm trial that is recruiting 60 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by PSMA PET. Participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. Participants will be follow-up as per standard of care up to 5 years post-treatment.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 2030 |
Est. primary completion date | August 2028 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men older than 18 years old. - Histologically proven initial diagnosis of adenocarcinoma prostate cancer. - Previous radical prostatectomy. - Biochemical relapse with local or regional recurrence proven on PSMA PET. - Five or less positive nodes on the PSMA PET. - ECOG 0-1 Exclusion Criteria: - Presence of para-aortic lymph nodes or distant metastasis. - Chronic pelvic inflammatory disease. - Contraindication for radiation treatment. - Previous radiation treatment within the pelvis |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Cancer Center | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Grade =2 Toxicity for GU | Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | Baseline to 5-year follow-up | |
Secondary | Biochemical Failure Free Survival | Biochemical control rate will be assessed at baseline and at each follow-up visit (1, 3, 6, 12, 18, 24, 36, 48, and 60 months) by the blood level of prostate-specific antigen (PSA) levels | Baseline to 5-year follow-up | |
Secondary | Patient-reported quality-of-life assessed by EPIC-26 | Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26) | Baseline to 5-year follow-up |
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