Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy

N/AActive Not RecruitingNCT04848909

Sunnybrook Health Sciences Centre30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

stereotactic body radiotherapy (SBRT)RADIATION

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Sunnybrook Odette Cancer Centre

Toronto, Onatrio, Canada

Outcomes

Primary Outcomes

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

Time frame: 6.5 years

Secondary Outcomes

Late Adverse Events/toxicities experienced by Participants

Incidence of late GU and GI toxicities (≥6 months) using CTCAE v5.0

Time frame: 6.5 years

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.

Time frame: 6.5 years

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

Time frame: 6.5 years

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.

Time frame: 6.5years

Health Utilities using EuroQol- 5 Dimension Questionnaire

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.