NCT04654338 2 Ablative RadioTherapy Treatments for Prostate Cancer
| NCT ID | NCT04654338 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-07-29 |
| Primary Completion | 2024-01-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2020-07-29 with a primary completion date of 2024-01-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 protracted courses of up to 39 treatments over 8 weeks. Stereotactic ablative body radiotherapy (SABR) protocols hold the promise of more convenience, less side effects, less cost and improved system capacity without sacrificing excellent cancer control rates. By the same token, prostate high-dose rate (HDR) brachytherapy boost has been shown to be superior to standard external beam radiation. While two HDR fractions appear to optimize patient convenience and outcomes while minimizing costs, we wanted to determine the tolerability of combining one MR-guided HDR treatment with one SABR treatment to further reduce HDR resource use while maintaining favourable treatment outcomes.
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
Contact & Investigator
Andrew Loblaw, MD
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT04654338 clinical trial?
This trial is open to male participants only, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04654338 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04654338 currently recruiting?
Yes, NCT04654338 is actively recruiting participants. Contact the research team at Merrylee.Mcguffin@sunnybrook.ca for enrollment information.
Where is the NCT04654338 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04654338 clinical trial?
NCT04654338 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Andrew Loblaw, MD at Sunnybrook Health Sciences Centre. The trial plans to enroll 30 participants.
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