Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy

Prostate Cancer Clinical Trial

— PLUTO-MPC  

Official title:

Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04848909
• Other study ID #: 3596
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: December 2027

Study information

• Verified date: October 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: Tiffany Tassopoulos
• Phone: 416-480-6100
• Email: tiffany.tassopoulos[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase I study will assess the toxicity profile and efficacy of SBRT (Stereotactic body radiotherapy) in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.

Description:

Radical prostatectomy is a common treatment for localized prostate cancer, patients with a detectable and/or rising PSA after radical prostatectomy may be offered radiation. An increasing number of patients are being referred post-operatively for radiotherapy, which creates an added burden on radiotherapy departments. Therefore, a strategy that could potentially decrease the number of radiotherapy fractions, yet maintain its efficacy, would be highly desirable for patient convenience, cost saving, and resource utilization as long as the toxicity profile is acceptable. This study will be conducted to asses the toxicity and efficacy of Stereotactic body radiotherapy (SBRT) in post-prostatectomy patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of adenocarcinoma of the prostate status post radical prostatectomy
• Completed written informed consent
• Able and willing to complete EPIC, PORPUS, and EQ-5D questionnaires
• A detectable PSA = 2.0 ng/ml
• Two consecutive rises in PSA and final PSA > 0.1 ng/ml OR three or more consecutive rises in PSA

Exclusion Criteria:

• Gross residual disease (per conventional imaging, i.e. CT and/or MRI)
• Histological or radiological node +ve (N1) or distant metastases (M1)
• Prior pelvic radiotherapy
• Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Sunnybrook Cancer center	Toronto	Onatrio

Sponsors (4)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Credit Valley Hospital, Princess Margaret Hospital, Canada, Royal Victoria Regional Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Adverse Events/toxicities experience by Participants	Incidence of acute GU and GI toxicities, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0	6.5 years
Secondary	Late Adverse Events/toxicities experienced by Participants	Incidence of late GU and GI toxicities (=6 months) using CTCAE v5.0	6.5 years
Secondary	Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire	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.	6.5 years
Secondary	Biochemical disease-free survival	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	6.5 years
Secondary	Health Utilities using The Patient-Oriented Prostate Utility Scale	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.	6.5years
Secondary	Health Utilities using EuroQol- 5 Dimension Questionnaire	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: Mobility; Self-care; Usual Activities; Pain/discomfort; Anxiety/depression	6.5years