High Dose-Rate Brachytherapy and/or Intensity Modulated External Beam Radiation Therapy for Prostate Cancer

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Adenocarcinoma of the Prostate

Treatments: Procedure: high dose-rate brachytherapy; Procedure: intensity-modulated radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00243321

MCC-02961

Details and patient eligibility

About

The principal objective of this study is to demonstrate that patients can safely receive combined High Dose Rate brachytherapy and Intensity-Modulated Radiation Therapy without experiencing a treatment limiting toxicity.

Full description

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.

Enrollment: 27 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

HDR brachytherapy -> IMRT

Experimental group

Description:

Radiotherapy

Treatment:

Procedure: high dose-rate brachytherapy

Procedure: intensity-modulated radiation therapy