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NCT Number: NCT00969111

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

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.

Recruiting

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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

Proton Center of Arkansas, Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
  • Maximum PSA value of 20 ng/ml.

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 the prescribed study treatment.
  • Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
  • Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
  • Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Treatment and study plan

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

Radiation

Postop High Risk

Proton (prostate bed) to 70.2 CGE

Radiation

Salvage Non-High Risk

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

Radiation

Salvage High Risk

Proton to 66.6 CGE

Radiation

Post-Op Non High Risk

Primary outcomes

  1. The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.

    Time frame: 6 months after the end of radiation therapy

Secondary outcomes

  1. Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters

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

Sponsors and collaborators

Lead sponsor

Proton Collaborative Group

Network

Collaborators

  • University of Florida Health

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2031
Study completion
2050
First posted
Aug 31, 2009
Registry last updated
Jun 17, 2026

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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