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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDR whole gland salvage treatment | Other | Locally recurrent prostate cancer Whole gland HDR brachytherapy administered Whole gland dose=10.5Gy x 2 fractions delivered one week apart GTV dose=13.5Gy x 2 fractions delivered one week apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDR brachytherapy | Radiation | Whole gland salvage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute GI toxicities | Acute GI toxicities using NCI CTCAE v4.0 | 3 mths post brachytherapy |
| Acute GU toxicities | Acute GU toxicities utilizing NCI CTCAE v4.0 | 3 moths post brachytherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Acute GU symptoms | Acute GU symptoms American Urological Association Symptom Index Score (IPSS) | 5 years |
| Late GU symptoms | Late GU symptoms American Urological Association Symptom Index Score (IPSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Chung, MD | Odette Cancer Centre, Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odette Cancer Centre, Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N3M5 | Canada |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 5 years |
| Late GI toxicities | Late GI toxicities using NCI CTCAE v.4.0 | 5 years |
| Late GU toxicities | Late GU Toxicities using NCI CTCAE v.4.0 | 5 years |
| Biochemical disease free survival | PSA | 5 years |
| Quality of Life (QoL) | QoL measured using Expanded Prostate Cancer Index Composite (EPIC) | 5 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |