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| Name | Class |
|---|---|
| Tolmar Pharmaceuticals | UNKNOWN |
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Prostate cancer is the most common cancer in men and radical prostatectomy is the most frequent treatment for this disease. Unfortunately, approximately 40% of patients will develop recurrence after surgery, requiring additional salvage radiation. Salvage radiation after recurrence is successful in less than half of these men and most of those die from their disease. Measures to prevent recurrence are an important research priority for prostate cancer patients and their families. Hormonal therapy (androgen deprivation therapy; ADT) is routinely used to treat patients with metastases, but few clinical trials have examined if adjuvant ADT after surgery will prevent cancer recurrence. We aim to address this research oversight and test the hypothesis that for men at high risk of cancer recurrence, 1 year of ADT immediately after surgery will be safe and will significantly improve cancer outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Standard of Care | |
| Standard of Care plus Androgen Deprivation Therapy (Lupron Depot) | Experimental | 22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lupron Depot | Drug | Patients randomized to receive androgen deprivation therapy (ADT) will receive 12 months of Lupron Depot (22.5 mg) administered every 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of enrolment | Rate (patients/month) of enrolment | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of enrolment per site | Rate (patients/month) of enrolment per site | 1 year |
| Proportion of patients completing study intervention per-protocol | Proportion of patients completing study intervention per-protocol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodney Breau, Dr. | Contact | 613-737-8899 | 73019 | rbreau@toh.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Scotia Health | Recruiting | Halifax | Nova Scotia | B3H 2Y9 | Canada |
N/A. IPD not planned to be shared
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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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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| 1 year |
| Time to study start-up | Time to study start-up at each site | 1 year |
| Completeness of study assessments | Proportion of study assessments completed per-protocol | 1 year |
| The Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
|
| Centre universitaire de santé McGill - McGill University Health Centre | Not yet recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |