Proton Therapy for Low and Intermediate Risk Prostate Cancer (PR04)

University of Florida

Status

Completed

Conditions

Prostate Cancer

Treatments

Radiation: Intermediate Risk Proton Radiation

Radiation: Low Risk Proton Radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT00693238

UFPTI 0702-PR04

IRB201701653 (Other Identifier)

UFJ 2008-022 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

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

Enrollment

228 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.