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Phase III Study of Mildly Hypo-fractionated Image Guided Proton Beam Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Phase III Study of Mildly Hypo-fractionated Image Guided Proton Beam Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate

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

- 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.

- IPSS ≤ 16.

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Morbidity Outcomes

Outcome Description:

To determine if androgen suppression along with high dose proton radiation therapy will result in a higher freedom from failure (FFF) than high dose proton 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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Carlos Vargas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Proton Collaborative Group


United States: Institutional Review Board

Study ID:




Start Date:

January 2012

Completion Date:

December 2021

Related Keywords:

  • Prostate Cancer
  • Prostate
  • proton
  • radiation
  • intermediate risk
  • Prostatic Neoplasms



ProCure Proton Therapy Center Warrenville, Illinois  60555
ProCure Proton Therapy Center Oklahoma City, Oklahoma  73142