Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer (PR07)

University of Florida

Status

Completed

Conditions

Prostate Cancer

Treatments

Radiation: 70 Gy/CGE

Radiation: 72.5 Gy/CGE

Study type

Interventional

Funder types

Other

Identifiers

NCT01368055

IRB201701768 (Other Identifier)

UFPTI 1103-PR07

Details and patient eligibility

About

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.

Enrollment

361 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).