Status:
ACTIVE_NOT_RECRUITING
PSMA MRI Guided Prostate SBRT (ARGOS)/Comprehensive, Longitudinal Evaluation of Imaging Biomarkers Post Radiotherapy (CLIMBER)
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This study is a prospective Phase I/II protocol enrolling men with either high intermediate-risk or high-risk or very high-risk prostate cancer. All men will have PSMA Targeted PET (using the PSMA tar...
Eligibility Criteria
Inclusion
- Age \> 18 years of age
- Histologically confirmed carcinoma of the prostate
- High-intermediate risk or high risk as defined by NCCN criteria:
- High intermediate: 2 or 4 intermediate risk factors (T2B-T2C, Gleason GG 2 or 3, PSA 10-20) or GG 3 or intermediate risk with equal or \>50% biopsy core involvement
- High-risk: one of T3a, Gleason GG 4 or 5, or PSA \>20 ng/ml
- Very-high risk: one of primary Gleason Pattern 5, \>4 cores Grade Group 4 or 5, clinical T3b, or more than 1 high-risk feature
- Conventional imaging (bone scan and abdominal pelvic computed tomography) negative for extra-pelvic nodal, skeletal or visceral metastases
- Willing to give informed consent to participate in this clinical trial
- Able and willing to complete EPIC questionnaires
Exclusion
- Prior prostate cancer treatment (apart from prior 5-alpha reductase inhibitor treatment); androgen deprivation therapy prior to enrollment or treatment planning not permitted
- Men with clinical T4 disease are excluded
- Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- Contraindication to prostate MRI (i.e. non0compatible stent, pacemaker, prosthesis, etc.)
- Contraindication to use of PSMA PET agent PSMA 1007 due to intolerance or allergy
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- Diagnosis of bleeding diathesis
- Poor baseline urinary function defined as a score of 5 ("big problem") on question 5 of the EPIC 26 (Overall, how big a problem has your urinary function been for you during the last 4 weeks?)
- Definitive extra-pelvic nodal or distant metastatic disease on conventional staging investigations
Key Trial Info
Start Date :
May 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05269550
Start Date
May 3 2022
End Date
December 15 2028
Last Update
July 28 2025
Active Locations (2)
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1
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
2
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N3M5