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Phase I Examination of Combination High Dose-Rate Brachytherapy and/or Intensity Modulated External Beam Therapy for the Comprehensive Local Treatment of Patients With Locally Confined Adenocarcinoma of the Prostate


Phase 1
N/A
N/A
Not Enrolling
Male
Adenocarcinoma of the Prostate

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Trial Information

Phase I Examination of Combination High Dose-Rate Brachytherapy and/or Intensity Modulated External Beam Therapy for the Comprehensive Local Treatment of Patients With Locally Confined Adenocarcinoma of the Prostate


Patients will receive a single High Dose Rate brachytherapy dose of 6 Gy to the prostate,
followed by 61 Gy delivered to the prostate and nearby tissues using Intensity-Modulated
Radiation Therapy in 28 treatments.


Inclusion Criteria:



- TRUS biopsy proven adenocarcinoma of the prostate Pretreatment PSA <30 ng/ml
Gleason's sum < 8 clinical stage T1 or T2a,b. patients that are at low-intermediate
risk for disease beyond the prostate normal liver function for all patients beginning
hormone therapy Karnofsky Performance score > 80 acceptable anesthesia risk as
determined through routine pre-operative screening in the VCUHS Diagnostic Testing
Clinic

Exclusion Criteria:

- pubic-arch interference or regional disease ( no evidence of metastatic disease for
patients whose PSA is greater than 10 ng/ml, Gleason's sum is greater than 6, or
T-stage is greater than T2a.

Patients at high risk for distant disease (PSA > 30 ng/ml, Gleason's sum > 8 or clinical
stage > T2c), clinically involved seminal vesicles or extension beyond the prostate
capsule history of inflammatory bowel disease require steroid or cytotoxic therapy for
collagen vascular disease uncontrolled or poorly controlled hypertension uncontrolled or
poorly controlled diabetes mellitus history of cancer other than skin cancer within five
years of the initiation of protocol treatment history of pelvic irradiation require the
routine use of warfarin

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To demonstrate that patients can safely receive combined HDR brachytherapy and IMRT teletherapy to a total dose consistent with current treatment policies and without experiencing a treatment limiting toxicity

Outcome Time Frame:

10 years

Safety Issue:

Yes

Principal Investigator

Michael P Hagan, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University

Authority:

United States: Institutional Review Board

Study ID:

MCC-02961

NCT ID:

NCT00243321

Start Date:

February 2003

Completion Date:

January 2012

Related Keywords:

  • Adenocarcinoma of the Prostate
  • brachytherapy
  • intensity-modulated radiation therapy
  • prostate specific antigen
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

Virginia Commonwealth University Richmond, Virginia