Status:
RECRUITING
2 Ablative RadioTherapy Treatments for Prostate Cancer
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE2
PHASE3
Brief Summary
Favorable-risk prostate cancer represent a large proportion of patients diagnosed with prostate cancer and image guided radiation therapy (IGRT) is commonly used to treat these patients using protract...
Detailed Description
Pre-Treatment: Planning CT and mpMRI imaging for SABR TRUS with biopsy and insertion of Gold Seed Fiducial Markers Biobanking of urine, blood and biopsy tissue (as per REB#079-2006 Odette Cancer Cent...
Eligibility Criteria
Inclusion Criteria:
-
Histologically confirmed diagnosis of adenocarcinoma of the prostate
-
Favorable risk disease defined as either:
- Low risk disease: T1-T2c, grade group 1, PSA < 10 ng/ml or
- Favorable intermediate risk disease: One of T2c, grade group 2, or PSA 10-20 ng/ml. Patients cannot have percent core positivity > 50%
-
Prostate volume < 60 cc as determined by US, CT or MRI
-
Ability to undergo MR imaging
-
Provide written informed consent
Exclusion Criteria:
- Documented nodal or distant metastases
- Previous pelvic radiotherapy
- Previous transurethral resection of prostate, previous prostatectomy or HIFU
- Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
- Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >15
- Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- Significant medical co-morbidity rendering patient unsuitable for general anaesthesia
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 29 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04654338
Start Date
July 29 2020
End Date
July 29 2028
Last Update
June 27 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5