Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy (PLUTO-MPC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04848909|
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : September 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: stereotactic body radiotherapy (SBRT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||men diagnosed with prostate cancer post-prostatectomy|
|Masking:||None (Open Label)|
|Official Title:||Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Multicenter Study|
|Actual Study Start Date :||June 3, 2021|
|Estimated Primary Completion Date :||December 2027|
|Estimated Study Completion Date :||December 2027|
Experimental: Men with prostate cancer post-prostatectomy
Men with localized prostate cancer who are considered candidates for post-prostatectomy radiation.
Radiation: stereotactic body radiotherapy (SBRT)
Stereotactic body or external-beam radiation therapy (SBRT) is a method of delivery of radiation in precision manner to the prostate bed in this study. The SBRT dose prescription will be 3000 cGy in 5 fractions to the prostate bed and 2500 cGy in 5 fractions to the pelvic nodes if elective nodal irradiation (ENI) is used, delivered every other business day.
- Early Adverse Events/toxicities experience by Participants [ Time Frame: 6.5 years ]Incidence of acute GU and GI toxicities, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- Late Adverse Events/toxicities experienced by Participants [ Time Frame: 6.5 years ]Incidence of late GU and GI toxicities (≥6 months) using CTCAE v5.0
- Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire [ Time Frame: 6.5 years ]Acute and late GU and GI quality of life (QoL) using the Expanded Prostate Cancer Index Composite questionnaire which evaluates participant's function and bother after prostate cancer treatment. Each question is scored from 1-5, 1 being the better outcome and 5 being the worst outcome.
- Biochemical disease-free survival [ Time Frame: 6.5 years ]Biochemical disease-free survival (bDFS), defined as survival until first evidence of either biochemical progression (PSA of 0.4 ng/mL or greater) following postoperative radiotherapy, PSA of more than 2.0 ng/mL at any time after postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol hormone therapy, or death from prostate cancer
- Health Utilities using The Patient-Oriented Prostate Utility Scale [ Time Frame: 6.5years ]Health utilities using The Patient-Oriented Prostate Utility Scale to measure health-related quality of life, whether it improves, deteriorates or stay the same. There are 10 questions, each questions has 5 possible answers, with 1 being the better outcome and 5 being the worst outcome.
- Health Utilities using EuroQol- 5 Dimension Questionnaire [ Time Frame: 6.5years ]
Health utilities using the EuroQol- 5 Dimension Questionnaire determines 5 variables, each with 5 possible options, with the first being the best outcome and the last being the worst outcome. The 5 variables include:
- Usual Activities
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): NCT04848909
|Contact: Tiffany Tassopoulos||416-480-6100 ext firstname.lastname@example.org|
|Contact: Kerri Durrant||416-480-6100 ext email@example.com|
|Sunnybrook Cancer center||Recruiting|
|Toronto, Onatrio, Canada, M4N 3M5|
|Contact: Kerri Durrant 416-480-6100 ext 89518 firstname.lastname@example.org|
|Principal Investigator: Chia-Lin Tseng, MD|
|Principal Investigator:||Dr. Chia-Lin Tseng, MD, FRCPC||Sunnybrook Health Sciences Centre|