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Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Proton Collaborative Group
Information provided by (Responsible Party):
Proton Collaborative Group Identifier:
First received: December 9, 2011
Last updated: December 14, 2016
Last verified: December 2016

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.

Condition Intervention Phase
Prostate Cancer
Radiation: Radiation
Drug: Androgen Suppression Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Image Guided Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate

Resource links provided by NLM:

Further study details as provided by Proton Collaborative Group:

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

    To determine if androgen suppression along with radiation therapy will result in a higher freedom from failure (FFF) than radiation therapy without androgen suppression.

    Freedom from failure (FFF): The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA) (45) discounting bounces per investigator discretion, or the start of salvage therapy including androgen suppression

Secondary Outcome Measures:
  • Frequency and severity of grade 2 or higher GU and GI toxicity [ Time Frame: At 6 months ]
    Assessment of grade 2 or higher GU and GI toxicity using CTCAE 4.0 criteria

  • Frequency and severity of GI and GU toxicity [ Time Frame: At 3 years ]
  • Incidence of quality of life issues [ Time Frame: At completion of radiation therapy ]
  • Incidence of Freedom from biochemical failure (FFBF) [ Time Frame: At 5 years ]
  • Incidence of clinical failure: local and/or distant [ Time Frame: At 5 years ]
  • Incidence of salvage Androgen Suppression use (SAD) [ Time Frame: At 5 years ]
  • Incidence of progression free survival: using clinical, biochemical and SAD as events [ Time Frame: At 5 years ]
  • Incidence of overall survival [ Time Frame: At 5 years ]
  • Incidence of disease-specific survival [ Time Frame: At 5 years ]
  • Correlate pathologic and radiologic findings with outcomes [ Time Frame: At 5 years ]
  • Correlate PSA and free PSA levels with outcomes [ Time Frame: At 5 years ]
  • Correlate testosterone levels and variation with proton therapy and outcomes [ Time Frame: At 5 years ]
  • Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity [ Time Frame: At 3 years ]

Estimated Enrollment: 192
Study Start Date: January 2012
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Radiation: 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)
Experimental: Radiation + Androgen Suppression
Androgen Suppression Therapy x 6 months + Radiation
Radiation: 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)
Drug: 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)
Other Name: leuprolide, goserelin, buserelin, or triptorelin


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01492972

Contact: Corey Woods, RN, MS, CCRC 630-836-8668

United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: : Clinical Trials Office - All Mayo Clinic Locations    855-776-0015 (toll free)      
United States, Illinois
Northwestern Medicine Chicago Proton Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: Shirley Samuel    630-657-0096      
Principal Investigator: John Chang, MD         
United States, Oklahoma
ProCure Proton Therapy Center Recruiting
Oklahoma City, Oklahoma, United States, 73142
Contact: Kayla Tarrant, MS, CCRC    405-773-6775   
Principal Investigator: Gary Larson, MD         
United States, Virginia
Hampton University Proton Therapy Institute Recruiting
Hampton, Virginia, United States, 23666
Contact: Karl Citerella    757-251-6800   
Principal Investigator: Christopher Sinesi, MD         
Sponsors and Collaborators
Proton Collaborative Group
Principal Investigator: Carlos Vargas, MD Proton Collaborative Group
  More Information

Responsible Party: Proton Collaborative Group Identifier: NCT01492972     History of Changes
Other Study ID Numbers: GU003-10
Study First Received: December 9, 2011
Last Updated: December 14, 2016

Keywords provided by Proton Collaborative Group:
intermediate risk

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Ascorbic Acid
Estrogens, Conjugated (USP)
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Growth Substances
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on May 22, 2017