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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Adenocarcinoma of the Prostate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HDR brachytherapy -> IMRT

Radiotherapy

Group Type EXPERIMENTAL

high dose-rate brachytherapy

Intervention Type PROCEDURE

High dose-rate brachytherapy

intensity-modulated radiation therapy

Intervention Type PROCEDURE

intensity-modulated radiation therapy

Interventions

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high dose-rate brachytherapy

High dose-rate brachytherapy

Intervention Type PROCEDURE

intensity-modulated radiation therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

MALE

Accepts Healthy Volunteers

No