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An Expanded Phase II Study of Hypofractionated Dose Intense 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

An Expanded Phase II Study of Hypofractionated Dose Intense Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate


Inclusion Criteria:



- Prostate cancer.

- Gleason score 2-6 or 7.

- PSA ≤ 20 ng/ml.

Exclusion Criteria:

- Previous prostate cancer surgery or pelvic radiation.

- Prior/concurrent systemic chemotherapy for prostate cancer.

- Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative
colitis) affecting the rectum.

- History of proximal urethral stricture requiring dilatation.

- History of hip replacement.

- Prior intrapelvic surgery.

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

- Receiving continuous and current anticoagulation with Warfarin sodium (Coumadin),
Clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa),enoxaparin
sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).

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:

Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.

Outcome Time Frame:

2 years after completion of radiation therapy

Safety Issue:

Yes

Principal Investigator

Randal H. Henderson, MD, MBA

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Proton Therapy Institute

Authority:

United States: Institutional Review Board

Study ID:

UFPTI 1103-PR07

NCT ID:

NCT01368055

Start Date:

September 2011

Completion Date:

September 2036

Related Keywords:

  • Prostate Cancer
  • Proton Radiation, Prostate Cancer
  • Prostatic Neoplasms

Name

Location

University of Florida Proton Therapy InstituteJacksonville, Florida  32206