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A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma


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

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Trial Information

A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma


Inclusion Criteria:



* Adenocarcinoma of the prostate.

Exclusion Criteria:

- Previous prostate cancer treatment.

- Prior systemic chemotherapy.

- Prior pelvic radiation.

- Active inflammatory bowel disease (diverticulitis, Crohn's disease or ulcerative
colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not
affecting the rectum are allowed.)

- History of hip replacement.

- Prior intrapelvic surgery. This includes the following:

- Transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding

- Transabdominal pelvic surgery

- Bladder surgery

- Prior MI (myocardial infarction) or CHF (congestive heart failure).

- 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:

Acute grade 3 or higher treatment-related toxicity rate.

Outcome Time Frame:

6 months after the completion of radiation therapy

Safety Issue:

Yes

Principal Investigator

Nancy P Mendenhall, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Proton Therapy Institute

Authority:

United States: Institutional Review Board

Study ID:

UFPTI 0703 - PR05

NCT ID:

NCT01040624

Start Date:

December 2009

Completion Date:

January 2035

Related Keywords:

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

Name

Location
University of Florida Proton Therapy Institute Jacksonville, Florida  32206