Proton Therapy for Low and Intermediate Risk Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: Intermediate Risk Proton Radiation; Radiation: Low Risk Proton Radiation

• Registration Number: NCT00693238
• Lead Sponsor: University of Florida

Brief Summary

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

Detailed Description

Low Risk - Total of 70 Gy/CGE over 28 treatments

Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2012-06
• Results First Submitted: 2013-03-14
• Results First Submitted QC: 2013-07-23
• Results First Posted: 2013-07-24
• Study Completion: 2022-04-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 228

Inclusion Criteria

Not provided

Exclusion Criteria

• Previous prostate cancer surgery or pelvic radiation.
• Prior or current chemotherapy for prostate cancer.
• Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
• History of proximal urethral stricture requiring dilatation.
• History of hip replacement.
• Diabetes requiring medication.
• Prior intrapelvic surgery.
• Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
• On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral (alfuzosin HCl).
• Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermediate Risk Proton Radiation	Intermediate Risk Proton Radiation	72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
Low Risk Proton Radiation	Low Risk Proton Radiation	70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx

Primary Outcome Measures

Name	Time	Method
Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.	6 months after the end of radiation therapy

Secondary Outcome Measures

Name	Time	Method
Disease Control	20 years after end of radiation

Trial Locations

Locations (1)

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