Recruiting
Phase 3

Radiation Therapy

Sponsor:

Proton Collaborative Group

Code:

NCT01492972

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation

Androgen Suppression Therapy

Study Details

Brief summary:

The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer.

Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

Conditions

Prostate Cancer

Study ID

NCT01492972

Start date

Jan, 2012

Status verified date

Sep, 2025

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA > = 10 and < = 20, T stage T2b - T2c
  • Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III).
  • Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. > 6 cores are strongly recommended.
  • PSA values < = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.
  • ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.
  • Patients must sign IRB approved study specific informed consent.
  • Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
  • Patients must be able to start treatment within 56 days of randomization.
  • Patients must be at least 18 years old.
  • For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve urination.
  • For brachytherapy, prostate volume must be less than 55cc prior to AS.

Exclusion Criteria:

  • Pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
  • Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
  • Previous pelvic radiation for prostate cancer.
  • Previous androgen suppression therapy for prostate cancer.
  • Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
  • Prior systemic chemotherapy for prostate cancer.
  • History of proximal urethral stricture requiring dilatation.
  • Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed).
  • Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study).
  • Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).
  • History of myocardial infarction within the last 6 months.

Study Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Radiation Alone

Proton Radiation Total Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR Brachytherapy and IMRT=45 Gy

experimental: Radiation + Androgen Suppression

Androgen Suppression Therapy x 6 months + Radiation

Interventions

Radiation

Consists of:

1. Conformal Proton Radiation Dose: 2.5 Gy (RBE) five days a week in 28 treatments over 5.5-6.5 weeks (total dose: 70 Gy (RBE))
2. High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy)
3. Intraoperative LDR Brachytherapy and IMRT: 100Gy Pad103 implant and IMRT 1.8 Gy five days a week in 25 treatments over 5-6 weeks (total dose: 45 Gy)

Androgen Suppression Therapy

Androgen suppression will begin 8 - 10 weeks prior to the start of RT for a total of 6 (+/- 2) months. Luteinizing Hormone-Releasing Hormone (LHRH) agonist therapy will consist of analogs approved by the FDA (or by Health Canada for Canadian institutions)

Primary outcome measure

  • Morbidity Outcomes [ Time Frame: after the initial 100 patients have had a median follow up of at least three years and then every year. ]

Central Contacts and Locations

Locations

Mayo Clinic

Recruiting

Scottsdale, Arizona, United States, 85259-5499

Contacts

: Clinical Trials Office - All Mayo Clinic Locations

855-776-0015 (toll free)

Northwestern Medicine Chicago Proton Center

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Don Smith, MS, CCRC

630-933-7820donald.smith3@nm.org

Principal Investigator:

Arpi Thukral, MD

Oklahoma Proton Center

Recruiting

Oklahoma City, Oklahoma, United States, 73142

Contacts

Angela Beebe

405-773-6708angela.beebe@okcproton.com

Principal Investigator:

John Chang, MD

Hampton University Proton Therapy Institute

Recruiting

Hampton, Virginia, United States, 23666

Contacts

Donna Sternberg, RN, BSN, OCN

757-251-6839donna.Sternberg@hamptonproton.org

Principal Investigator:

Christopher Sinesi, MD

More Information

Sponsor

Proton Collaborative Group

Last update posted

Sep 4, 2025

Last verified

Sep, 2025

Keywords

  • Prostate
  • proton
  • radiation
  • intermediate risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Proton Collaborative Group on 2025-09-04.