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Completed

NCT Number: NCT01368055

Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer

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.

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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, 32209, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Prostate cancer.
  • Gleason score 2-6 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).

Treatment and study plan

70 Gy/CGE

Radiation

Low Risk

72.5 Gy/CGE

Radiation

Intermediate Risk

Primary outcomes

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

    Time frame: 2 years after completion of radiation therapy

Secondary outcomes

  1. Analyzation of quality of life

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

  2. Analysis of treatment-related morbidity

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

  3. Analysis of disease control

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

    Proportion of patients with disease control after completion of treatment

  4. Analysis of overall survival

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

    Proportion of patients alive after completion of treatment

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

An Expanded Phase II Study of Hypofractionated Dose Intense Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate

Acronym: PR07

Important dates

Study start
2011
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2011
Registry last updated
Aug 29, 2025

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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