NCT06369246

PRORAD-5 PROstate RADiation in 5 Fractions: Phase II Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer.

Detailed description

Primary Objectives: Primary Objective #1: To determine the proportion of patients experiencing late grade ≥ 3 GI toxicity after five fraction pelvic nodal RT as reported by the treating physician at 3 months post-treatment. Primary Objective #2: To estimate the change in health-related quality of life (HRQOL) following the proposed treatment regimen compared to pre-treatment assessment 6 months after completing RT. Patient-reported urinary, bowel, and sexual function and general QoL will be collected using validated EPIC-26, EQ-5D, PROMIS-Fatigue questionnaires prior to RT, at the end of RT 3, and 6, 12, 24 months after completion of RT. Secondary Objectives: Secondary Objective #1: To estimate the metastasis free survival (MFS) at 24 months after study enrollment. All time-to-event analyses will be analyzed indexed to date of study enrollment. Secondary Objective #2: To estimate the rate of acute and late GI and GU toxicity of the treatment regimen Secondary Objective #3: To assess adherence to protocol treatment parameters. RT plans will be evaluated for contouring consistency, target coverage and tissue constraint adherence with the use of artificial intelligence (AI) auto-segmentation/contours and scorecards to facilitate this process and improve plan quality and clinical efficiency. Secondary Objective #4: To explore the impact of five fraction pelvic nodal RT on lymphopenia. White blood cell counts will be obtained before and after treatment and compared to historical data on lymphopenia with conventionally fractionated pelvic RT. Secondary Objective #5: To estimate HRQOL following the proposed treatment regimen compared to pre-treatment assessment at the end of RT 3 months, 12, and 24 months after completing RT and assess the HRQOL change over time. Exploratory Objective #1: To investigate the effect of pelvic nodal RT on gut microbiome with gut microbiome sample collection pre- and upon RT completion.

Conditions

• Advanced Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Stereotactic Body Radiation Therapy	Undergo Radiation Therapy

Timeline

• Start date: 2024-06-27
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-04-16
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study