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A Phase II Study of Hypofractionated Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Phase II Study of Hypofractionated Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate


Low Risk - Total of 70 Gy/CGE over 28 treatments

Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments


Inclusion Criteria:

3.1 Eligibility Criteria

- Clinical stages T1a-T2b prostate cancer.

- Maximum combined Gleason score 2-7.

- PSA must have always been ≤ 20 ng/ml.

Exclusion Criteria:

- Previous prostate cancer surgery and pelvic radiation.

- Prior or current chemotherapy for prostate cancer.

- 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).

- History of proximal urethral stricture requiring dilatation.

- History of hip replacement.

- Diabetes requiring medications.

- Prior intrapelvic surgery.

- Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel
bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole
(Aggrenox).

- On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral
(alfuzosin HCl).

- Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use
during radiation.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Collect and analyze morbidity outcomes.

Outcome Time Frame:

after radiation; every 6 months for 3 years; then annually

Safety Issue:

Yes

Principal Investigator

Randal H Henderson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida

Authority:

United States: Institutional Review Board

Study ID:

UFPTI 0702-PR04

NCT ID:

NCT00693238

Start Date:

April 2008

Completion Date:

December 2014

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Proton Radiation
  • Prostatic Neoplasms

Name

Location

University of Florida Proton Therapy InstituteJacksonville, Florida  32206