Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: 72.5 Gy/CGE; Radiation: 70 Gy/CGE

• Registration Number: NCT01368055
• Lead Sponsor: University of Florida

Brief Summary

The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Study Start: 2011-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2036-09
• Study Completion: 2036-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 361

Inclusion Criteria

• Prostate cancer.
• Gleason score 2-6 or 7.
• PSA ≤ 20 ng/ml.

Exclusion Criteria

• Previous prostate cancer surgery or pelvic radiation.
• Prior/concurrent systemic chemotherapy for prostate cancer.
• Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
• History of hip replacement.
• Prior intrapelvic surgery.
• Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its uses during radiation.
• Receiving continuous and current anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa),enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermediate Risk	72.5 Gy/CGE	72.5 Gy/CGE
Low Risk	70 Gy/CGE	70 Gy/CGE

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.	2 years after completion of radiation therapy

Secondary Outcome Measures

Name	Time	Method
Analyzation of quality of life	After radiation: every 6 months for 3 years, then annually for 20 years
Analysis of treatment-related morbidity	Cumulative incidence up to 20 years after completion of radiation therapy
Analysis of disease control	Cumulative incidence up to 20 years after completion of radiation therapy	Proportion of patients with disease control after completion of treatment
Analysis of overall survival	Cumulative incidence up to 20 years after completion of radiation therapy	Proportion of patients alive after completion of treatment

Trial Locations

Locations (1)

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States