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A single high dose rate brachytherapy (HDR) treatment combined with a short course of external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men with intermediate risk prostate cancer. High cancer control rates have also been reported with HDR used on its own, without the EBRT. The challenge has been to determine what HDR dose to use with a move towards one or two fractions by several investigators. These schedules are reported to be well tolerated in the short term, but with little long term data. The objective of this study is to investigate HDR monotherapy given as either one fraction of 19 Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The primary endpoint is patient reported toxicity and health related quality of life at 1 year, and efficacy data will be also be analyzed. Sample size for the study is 174 patients, which we expect to accrue within 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDR 2 fractions | Experimental | HDR brachytherapy of 27 Gy delivered in 2 fractions one week apart |
|
| HDR 1 fraction | Experimental | HDR brachytherapy of 19 Gy delivered in a single fraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDR 2 Fraction | Radiation | High dose-rate brachytherapy using real-time intra-operative transrectal ultrasound guidance. Patients will receive 27 Gy as a minimal Clinical Target Volume (CTV) dose delivered as two fractions of 13.5 Gy 7-13 days apart. The CTV is the ultrasound defined prostate with a 0-2 mm margin. |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life (QoL) | To demonstrate that health related QoL at 1 year in the urinary and bowel domains of the Expanded Prostate Index Composite (EPIC) for at least one HDR monotherapy arm is not worse than that following current standard treatment with single fraction HDR combined with supplemental external beam radiotherapy. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| GU and GI toxicities | To determine genito-urinary (GU) and gastro-intestinal (GI) toxicities in both study arms according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0 | baseline, 6 weeks post treament, 3mths, 6mths, 6 monthly for the first 3 years, annually up to 5 years |
| Urinary Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Morton, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odette Cancer Centre, Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 11, 2023 | |
| Reset | Jan 12, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 11, 2023 | Jan 12, 2024 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| HDR 1 Fraction | Radiation | High Dose-Rate Brachytherapy delivered in same manner as Arm 1, but to a prescribed CTV minimal dose of 19 Gy in a single fraction |
|
To determine changes in urinary symptoms in both study arms as determined by the International Prostate Symptom Score (IPSS) |
| baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly for the first 3 years, annually until 5 years |
| Serum PSA changes | To determine changes in serum prostate-specific antigen (PSA) in both arms | baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly up to 3 years, annually until 5 years |
| Biochemical failure and disease free survival rates | To determine PSA failure and disease free survival rates in both study arms | 5 years |
| Erectile function | To determine changes in erectile function in both study arms assessed using the International Index of Erectile Function (IIEF) scale | 5 year |
| Associations between dosimetric parameters and toxicity/EPIC domains | To explore association between dosimetric parameters and toxicity/EPIC domain change | 5 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |