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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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This is a multi-centre, investigator-initiated, two-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor to standard of care radiation and hormone therapy improve quality of life.
Participants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3). Participants will be routinely follow-up in clinic or remotely for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Standard of Care | Other | Participants in this group will receive standard of care radiation treatment and ADT. Participants will start ADT first. Androgen deprivation therapy will be delivered via injection every 4 months as per standard of care (for 8 months total). At the same time, or within 3 months of starting ADT, participants will begin radiation treatment. The radiation treatment course will consist of 2-5 sessions of radiation daily or every other day (the number of sessions will be determined by the physician depending on the location of cancer, number of cancer spots, etc.). |
|
| Arm 3 - Study Treatment | Experimental | Participants in this group will receive standard of care radiation treatment and ADT, plus abiraterone. Participants will start ADT first. Androgen deprivation therapy will be delivered via injection every 4 months as per standard of care (for 8 months total). At the same time, or within 3 months of starting ADT, participants will begin radiation treatment. The radiation treatment course will consist of 2-5 sessions of radiation daily or every other day (the number of sessions will be determined by the physician depending on the location of cancer, number of cancer spots, etc.). In addition, participants will take abiraterone orally (by mouth) daily for 8-9 months. Participants will start the first pill within a month of enrollment. This pill can be taken around the same time of day with or without food. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | Second-generation androgen pathway inhibitor (ARAT), oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Determine if progression free survival improves with the addition of intermittent enzalutamide to standard of care treatment. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported quality of life | Determine if the addition of intermittent enzalutamide to standard of care treatment results in a patient-reported quality of life difference compared to standard of care treatment alone using quality of life questionnaires (EPIC-26). | 5 years |
| Patient-reported quality of life |
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Inclusion Criteria:
Age > 18 years
Able to provide informed consent
Histologic diagnosis of prostate adenocarcinoma
ECOG performance status 0-2
Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases
All sites of disease are amenable to and can be safely treated with radiotherapy
Patients decline continuous use of ADT
Exclusion Criteria:
Male participants only as this study is in metastatic prostate cancer.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Glicksman, MD | Contact | 416-946-4961 | rachel.glicksman@uhn.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Center | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| Standard of Care SBRT and ADT | Other | Standard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT) |
|
Determine if the addition of intermittent enzalutamide to standard of care treatment results in a patient-reported quality of life difference compared to standard of care treatment alone using quality of life questionnaires (FACT-P). |
| 5 years |
| Patient-reported quality of life | Determine if the addition of intermittent enzalutamide to standard of care treatment results in a patient-reported quality of life difference compared to standard of care treatment alone using quality of life questionnaires (FACT-Fatigue). | 5 years |
| Physician-reported toxicity | Determine if the addition of intermittent enzalutamide to standard of care treatment results in a physician-reported difference in acute and late toxicities compared to standard of care treatment alone assessed by CTCAE Toxicity 5.0. | 5 years |
| Sunnybrook Research Institute | Active, not recruiting | Toronto | Ontartio | M4N 3M5 | Canada |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
| D000726 | Androgen Antagonists |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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