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Completed

NCT Number: NCT00693238

Proton Therapy for Low and Intermediate Risk Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Risk Proton Radiation

Radiation

Intermediate Risk Proton Radiation

Radiation

Primary outcomes

  1. 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

  1. Disease Control

    Time frame: 20 years after end of radiation

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

A Phase II Study of Hypofractionated Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate

Acronym: PR04

Important dates

Study start
2008
Primary completion
2012
Study completion
2022
First posted
Jun 6, 2008
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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