Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5, Canada
NCT Number: NCT02560181
Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% of patients who recur, there is no consensus on the optimal salvage therapy. 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 (cryotherapy), 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. The aim of this pilot study is to look at the feasibility and toxicities of whole gland salvage treatment of the prostate using temporary implantation of radioactive seeds into the prostate.
This study is active but is not currently recruiting participants.
Male
Interventional
Not applicable
Toronto, Ontario, M4N3M5, Canada
Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% of patients who recur, there is no consensus on the optimal salvage therapy. 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 (cryotherapy), 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. The aim of this pilot study is to look at the feasibility and toxicities of whole gland salvage treatment of the prostate using temporary implantation of radioactive seeds into the prostate. Reports of the efficacy and toxicities of whole gland salvage HDR brachytherapy for local recurrence after external beam radiation therapy are limited to single-institution studies with small sample sizes. Given that our institution has the highest volume of prostate brachytherapy cases in Ontario and that we receive a significant number of referrals from other cancer centres for brachytherapy, this study will aim to add to the literature and help guide salvage therapy practice within our institution.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Whole gland salvage
Time frame: 3 mths post brachytherapy
Acute GI toxicities using NCI CTCAE v4.0
Time frame: 3 moths post brachytherapy
Acute GU toxicities utilizing NCI CTCAE v4.0
Time frame: 5 years
Acute GU symptoms American Urological Association Symptom Index Score (IPSS)
Time frame: 5 years
Late GU symptoms American Urological Association Symptom Index Score (IPSS)
Time frame: 5 years
Late GI toxicities using NCI CTCAE v.4.0
Time frame: 5 years
Late GU Toxicities using NCI CTCAE v.4.0
Time frame: 5 years
PSA
Time frame: 5 years
QoL measured using Expanded Prostate Cancer Index Composite (EPIC)
Sunnybrook Health Sciences Centre
Other
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