Feasibility Trial in Men With Hormone Sensitive Oligometastatic Prostate Cancer (PRORAD)
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|ClinicalTrials.gov Identifier: NCT03301701|
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hormone Sensitive Oligometastatic Prostate Cancer||Procedure: Radical prostatectomy Radiation: HDR (19Gy) or SBRT (35-40Gy)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Feasibility Trial of Prostate Radiotherapy vs Prostatectomy in Men With Hormone Sensitive Oligometastatic Prostate Cancer|
|Actual Study Start Date :||September 22, 2017|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||January 2024|
Experimental: Arm 1
Procedure: Radical prostatectomy
Active Comparator: Arm 2
Radiation: HDR (19Gy) or SBRT (35-40Gy)
Patients will receive HDR unless judged to medically unfit to undergo HDR brachytherapy, in which case they will receive SBRT
- Patients willing to accept their randomization [ Time Frame: 2 years ]Patients willing to accept their randomization will be measured as a proportion.
- Toxicity [ Time Frame: 7 years ]Acute and late toxicities will be measured using CTCAE v4.0 and will be reported as percentages.
- Efficacy [ Time Frame: 7 years ]Time to CRPC will be calculated using Kaplan Meier methodology.
- Efficacy [ Time Frame: 7 years ]Progression free survival will be calculated using Kaplan Meier methodology.
- Efficacy [ Time Frame: 7 years ]Local control will be calculated using Kaplan Meier methodology.
- Efficacy [ Time Frame: 7 years ]Distant control will be calculated using Kaplan Meier methodology.
- Efficacy [ Time Frame: 7 years ]Overall survival will be calculated using Kaplan Meier methodology.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301701
|Contact: Merrylee McGuffin||416-480-5000 ext firstname.lastname@example.org|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N3M5|
|Contact: Merrylee McGuffin 416-480-5000 ext 6104 email@example.com|
|Principal Investigator:||Patrick Cheung||Sunnybrook Health Sciences Centre|