NCT05269550Active, not recruiting
PSMA MRI Guided Prostate SBRT (ARGOS)/Comprehensive, Longitudinal Evaluation of Imaging Biomarkers Post Radiotherapy (CLIMBER)
PSMA MRI Guided Prostate SBRT(ARGOS)/Comprehensive, Longitudinal Evaluation of Imaging Biomarkers Post Radiotherapy (CLIMBER)
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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 targeting ligand PSMA 1007) and multiparametric magnetic resonance imaging (mpMRI) for delineation of intra-prostatic foci of cancer and any involved regional lymph nodes based on high SUV uptake on PET or mpMRI (T2W, DWI/ADC, DCE) appearance suspicious for cancer. Tumour delineation will be performed by fusing the PSMA PET and mpMRI with planning CT simulation images. Fiducial marker implantation for treatment guidance will be mandatory but use of other organs at risk protection strategies (i.e. GU Loc, Space-OAR) will be allowed but not mandatory. Patients will be treated with image-guided SBRT using the fiducial markers for intra-fraction motion management. Dose escalation to imaging defined targets (intra-prostatic and involved nodes on PSMA PET + MRI) will be accomplished through a simultaneous boost technique. Maintaining dose to organs at risk will take precedence over boost dose targets (targeted maximum dose of 50Gy/5 fractions to imaging defined prostatic lesion; 35Gy/5 fractions to imaging defined involved nodes). Cohort extension: We hypothesize that integration of neoadjuvant androgen deprivation therapy will provide for pretreatment cancer downstaging and will allow us to achieve higher target doses to the imaging defined DILs than currently achieve. Additionally, we plan to include a novel sodium MRI protocol into the baseline imaging to compare DIL volumes delineated by this modality to those by mpMRI and PSMA PET and to characterize changes in sodium MRI in response to ADT alone and subsequent radiotherapy
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 12 Jan 2022
- Start date
- 3 May 2022
- Primary completion date
- 15 Dec 2028
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Diseases
- Prostate cancer
- NCT number
- NCT05269550
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 3 May 2022 to the primary completion date, 15 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior prostate cancer treatment (apart from prior 5-alpha reductase inhibitor treatment); androgen deprivation therapy prior to enrollment or treatment planning not permitted
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
Other illness
- Men with clinical T4 disease are excluded
- Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- Contraindication to use of PSMA PET agent PSMA 1007 due to intolerance or allergy
- Diagnosis of bleeding diathesis
- Definitive extra-pelvic nodal or distant metastatic disease on conventional staging investigations
Other
- Contraindication to prostate MRI (i.e. non0compatible stent, pacemaker, prosthesis, etc.)
- 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?)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Sunnybrook Research Institute Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.