An interventional study of focal salvage HDR prostate brachytherapy in Prostate Cancer, sponsored by Sunnybrook Health Sciences Centre. Active, not recruiting at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% who recur, a proportion of them will present with an isolated local recurrence, meaning no distant metastases. If left untreated, it may serve as a source for subsequent metastases. Salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease, and high frequency ultrasound to treat the disease. There are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. Therefore, the aim of this pilot study is to look at the feasibility and toxicities of focal treatment of the prostate using temporary implantation of radioactive seeds into the prostate which the investigators hope will be less since the entire prostate is not treated.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 60 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiation: focal salvage HDR prostate brachytherapy
Treatment will be delivered using 192-Ir HDR afterloading. Dose prescription is 2 fractions of 13.5 Gy each, delivered 1 week apart.
Incidence of acute urinary and rectal toxicities
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Acute period (<6 months)
Incidence of late urinary and rectal toxicities
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Late period (>6 months)
Biochemical (ie. prostate specific antigen) disease free survival
Time frame: 5 years
Quality of Life (QoL)
Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 5 years
Acute and late urinary toxicities
American Urological Association Symptom Index Score (i.e. IPSS)
Time frame: 5 years
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre