Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity

Recruiting

• Conditions: Prostate Cancer (CRPC)

• Registration Number: NCT07077239
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

Single-arm, prospective registry study assessing changes in acute patient-reported urinary (GU) and gastrointestinal (GI) quality of life at the 24-month post-treatment time point following magnetic resonance imaging (MRI)-guided or computed tomography (CT)-guided stereotactic body radiotherapy (SBRT) delivered to the prostate bed +/- pelvic lymph nodes. The decision to offer an adaptive treatment will be at the clinician's discretion.

Detailed Description

This project is a single-arm, prospective study assessing changes in acute patient-reported urinary (GU) and gastrointestinal (GI) quality of life at the 24-month post-treatment time point following magnetic resonance imaging (MRI)-guided or computed tomography (CT)-guided stereotactic body radiotherapy (SBRT) delivered to the prostate bed +/- pelvic lymph nodes. There is no pre-specified target enrollment for patients undergoing standard non-adaptive SBRT. The target enrollment of patients undergoing adaptive treatment is 200 patients. The rate of accrual is expected to be in the range of 40 patients per year.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-11
• Study Start: 2025-07-17
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-24
• Primary Completion: 2035-08-01
• Study Completion: 2036-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genitourinary Domain Score	5 years	To determine the rate of 2x MCID changes in any genitourinary domain score of the patient-reported EPIC-26 QOL tool at any point between the start of treatment and 24-months following CT-guided or MRI-guided adaptive stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes.

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Domain Score	5 years	To determine the rate of 2x MCID changes in any gastrointestinal domain score of the patient-reported EPIC-26 QOL tool at any point between baseline and 24 months following CT-guided or MRI-guided adaptive stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to historical control data for non-adaptive post-prostatectomy SBRT regimens.
Sexual Domain Score	5 years	To determine the rate of 2x MCID changes in any sexual domain score of the patient-reported EPIC-26 QOL tool at any point between the start of treatment and 24-months following CT-guided or MRI-guided adaptive stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to historical control data for non-adaptive post-prostatectomy SBRT regimens.
Change in IPSS Score	5 years	To quantify changes in IPSS score at 3 month intervals within the first 12 months of treatment, then at 6 month intervals thereafter until 5 years.
Long-Term Patient Reported GU Symptoms	5 years	To quantify long-term patient-reported GU symptoms using the EPIC-26 instrument at 6 month intervals between 24 months and 5 years.
Long-Term Patient-Reported GI Symptoms	5 years	To quantify long-term patient-reported GI symptoms using the EPIC-26 instrument at 6 month intervals between 24 months and 5 years.
GU and GI Adverse Events	5 years	To quantify rates and severity of acute physician scored GU and GI adverse events using the Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) scale.
Five-year Cumulative Incidence of GU and GI Adverse Events	5 years	To quantify the five-year cumulative incidence of physician scored GU and GI adverse events using the CTCAE v5.0 scale.
Progression-Free Survival	5 years	quantify five-year progression-free survival.
Biochemical Recurrence	5 Years	To quantify 5-year cumulative incidence of biochemical recurrence.
Distant Metastasis-Free Survival	5 years	To quantify 5-year distant metastasis-free survival.

Trial Locations

Locations (1)

University of California at Los Angeles; 🇺🇸 Los Angeles, California, United States