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RecruitingNCT01492972Updated Sep 29, 2026

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

A Phase 3 interventional study of Radiation and Androgen Suppression Therapy in Prostate Cancer, sponsored by Proton Collaborative Group. Recruiting at 4 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Proton Collaborative Group · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate
  • proton
  • radiation
  • intermediate risk
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
192 participants (estimated)

Study 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

    Radiation: Radiation

  • Experimental
    Radiation + Androgen Suppression

    Androgen Suppression Therapy x 6 months + Radiation

    Radiation: Radiation · Drug: Androgen Suppression Therapy

Interventions

  • RadiationRadiation

    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)

  • DrugAndrogen 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)

    Also known as: leuprolide, goserelin, buserelin, or triptorelin

05

What researchers measure

Primary outcomes

  1. Morbidity Outcomes

    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

    Time frame: after the initial 100 patients have had a median follow up of at least three years and then every year.

Secondary outcomes

  1. Frequency and severity of grade 2 or higher GU and GI toxicity

    Assessment of grade 2 or higher GU and GI toxicity using CTCAE 4.0 criteria

    Time frame: At 6 months

  2. Frequency and severity of GI and GU toxicity

    Time frame: At 3 years

  3. Incidence of quality of life issues

    Time frame: At completion of radiation therapy

  4. Incidence of Freedom from biochemical failure (FFBF)

    Time frame: At 5 years

  5. Incidence of clinical failure: local and/or distant

    Time frame: At 5 years

  6. Incidence of salvage Androgen Suppression use (SAD)

    Time frame: At 5 years

  7. Incidence of progression free survival: using clinical, biochemical and SAD as events

    Time frame: At 5 years

  8. Incidence of overall survival

    Time frame: At 5 years

  9. Incidence of disease-specific survival

    Time frame: At 5 years

  10. Correlate pathologic and radiologic findings with outcomes

    Time frame: At 5 years

  11. Correlate PSA and free PSA levels with outcomes

    Time frame: At 5 years

  12. Correlate testosterone levels and variation with proton therapy and outcomes

    Time frame: At 5 years

  13. Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity

    Time frame: At 3 years

06

Study locations

4 of 4 sites recruiting
  • Mayo Clinic
    Scottsdale, Arizona 85259-5499, United States
    • : Clinical Trials Office - All Mayo Clinic Locations · Contact · 855-776-0015 (toll free)
    Recruiting
  • Northwestern Medicine Chicago Proton Center
    Warrenville, Illinois 60555, United States
    • Don Smith, MS, CCRC · Contact · donald.smith3@nm.org · 630-933-7820
    • Arpi Thukral, MD · Principal investigator
    Recruiting
  • Oklahoma Proton Center
    Oklahoma City, Oklahoma 73142, United States
    Recruiting
  • Hampton University Proton Therapy Institute
    Hampton, Virginia 23666, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT01492972
Lead sponsor
Proton Collaborative Group
Responsible party
Sponsor
First posted
Dec 15, 2011
Start date
Jan 2012
Primary completion
Dec 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Carlos Vargas, MD
principal investigator · Proton Collaborative Group

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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