Proton Therapy for Low and Intermediate Risk Prostate Cancer

University of Florida228 enrolled

Overview

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.

Low Risk - Total of 70 Gy/CGE over 28 treatments Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

228

Conditions

Prostate Cancer

Interventions

Low Risk Proton RadiationRADIATION

Intermediate Risk Proton RadiationRADIATION

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * Prostate cancer. * Gleason score 2-7. * PSA ≤ 20 ng/ml. 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.

Locations (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.

Time frame: 6 months after the end of radiation therapy

Secondary Outcomes

Disease Control

Time frame: 20 years after end of radiation

Data from ClinicalTrials.gov

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