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Virus Therapy
MR-guided Radiotherapy for Recurrent Prostate Cancer
N/A
Recruiting
Led By Alejandro Berlin, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Absence of known metastatic disease
Salvage ADT to be started when PSA reaches a value of 6.0ng/ml or greater.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing a new way to find and treat recurrent prostate cancer that has come back after initial treatment. The new method uses a PET scan combined with MR imaging to more accurately find where the cancer has come back, and then uses image-guided radiation therapy to treat it. The hypothesis is that this novel approach will transform lives by detecting the cancer earlier and treating it more effectively.
Who is the study for?
This trial is for men with prostate cancer recurrence after surgery and radiotherapy, who have rising PSA levels but no visible metastases on scans. They should be in good health overall, able to lie still for imaging and treatment, not on hormone therapy recently or planning to start it, and without severe kidney issues or certain blood disorders.Check my eligibility
What is being tested?
The study tests a new PET/MRI scan using [18F]DCFPyL to find tiny cancer spread post-prostatectomy that standard scans can't see. Men with detected cancer spots will then receive precise Stereotactic Ablative Radiotherapy (SABR) aimed at eradicating these tumors.See study design
What are the potential side effects?
Potential side effects from the SABR may include fatigue, skin reactions in treated areas, urinary issues like increased frequency or discomfort, bowel changes such as diarrhea or rectal bleeding, and less commonly erectile dysfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not spread to other parts of my body.
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I will start hormone therapy when my PSA level is 6.0ng/ml or higher.
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I had surgery to remove my prostate due to cancer.
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My kidneys work well (GFR over 30).
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I do not have sickle cell disease or other blood disorders.
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I weigh less than 136kg, suitable for an MRI scan.
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I haven't used hormone therapy for cancer in the last year.
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My PSA levels have increased three times after prostate cancer treatments.
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I am able to get out of my bed or chair and move around.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine if [18F]DCFPyL PET-MR/CT can identify early oligometastatic disease in patients with a rising PSA and negative staging (CS and BS) after standard-of-care maximal local therapies.
To determine if treating PET-MR/CT identified lesions with curative-intent treatment (e.g. stereotactic body radiation therapy or surgery) associated with favorable preliminary measures of clinical performance.
Secondary outcome measures
Correlate between tissue biomarker and distant disease
Correlation between PSA kinetics and PET imaging parameters
Other outcome measures
Biomarker correlates
Concordance of PET-MR/CT finding and histological confirmation of metastatic foci.
[18F]DCFPyL PET/MR and PET/CT comparison
Trial Design
1Treatment groups
Experimental Treatment
Group I: [18F] DCFPyL PET/MRIExperimental Treatment2 Interventions
[18F] DCFPyL PET/MRI scans for patients with recurrent disease after radical prostatectomy and adjuvant/salvage radiotherapy.
Lesions identified through [18F] DCFPyL PET/MRI will be treated with stereotactic ablative radiotherapy (SABR) or surgery.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,475 Previous Clinical Trials
484,990 Total Patients Enrolled
Alejandro Berlin, MDPrincipal InvestigatorPrincess Margaret Cancer Centre - University Health Network
2 Previous Clinical Trials
2,258 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any participant slots still open for this trial?
"Confirmation from clinicaltrials.gov reveals that this investigation is presently recruiting participants and was published on May 23rd 2017, with the latest update being recorded on December 31st 2021."
Answered by AI
What is the maximum capacity of participants for this clinical experiment?
"Affirmative. According to information found on clinicaltrials.gov, this experiment is still enrolling participants as of today. It was first launched on May 23rd 2017 and most recently updated on December 31st 2021 with the aim of recruiting a total 100 volunteers from a single site."
Answered by AI
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