Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer

University of Florida361 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

361

Conditions

Prostate Cancer

Interventions

70 Gy/CGERADIATION

Low Risk

72.5 Gy/CGERADIATION

Intermediate Risk

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.

Time frame: 2 years after completion of radiation therapy

Secondary Outcomes

Analyzation of quality of life

Time frame: After radiation: every 6 months for 3 years, then annually for 20 years

Analysis of treatment-related morbidity

Time frame: Cumulative incidence up to 20 years after completion of radiation therapy

Analysis of disease control

Proportion of patients with disease control after completion of treatment

Time frame: Cumulative incidence up to 20 years after completion of radiation therapy

Analysis of overall survival

Proportion of patients alive after completion of treatment

Time frame: Cumulative incidence up to 20 years after completion of radiation therapy

Data from ClinicalTrials.gov

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