Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

Last updated: May 30, 2024
Sponsor: Proton Collaborative Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Prostate Disorders

Treatment

IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE

IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE

Proton (prostate bed) to 70.2 CGE

Clinical Study ID

NCT00969111
GU010-18
UFPTI 0902-PR06
  • Ages > 18
  • Male

Study Summary

The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Prostate cancer treated primarily with open, laparoscopic or robotically assistedprostatectomy.

  • Maximum PSA value of 20 ng/ml.

Exclusion

Exclusion Criteria:

  • Evidence of distant metastasis (M1).

  • Prior systemic chemotherapy for any reason.

  • Previous irradiation to the pelvis that would compromise the ability to deliver theprescribed study treatment.

  • Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerativecolitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease notaffecting the rectum are allowed).

  • History of hip replacement.

  • Prior or concurrent cancer, other than non-melanomatous skin cancer, unless diseasefree for at least 5 years.

  • Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its useduring radiation.

Study Design

Total Participants: 70
Treatment Group(s): 4
Primary Treatment: IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Phase:
Study Start date:
August 01, 2009
Estimated Completion Date:
August 31, 2050

Connect with a study center

  • University of Florida Proton Therapy Institute

    Jacksonville, Florida 32206
    United States

    Active - Recruiting

  • Northwestern Medicine Chicago Proton Center

    Warrenville, Illinois 60555
    United States

    Active - Recruiting

  • Inova Schar Cancer Institute

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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