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Completed

NCT Number: NCT00243321

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

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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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298-0058, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high dose-rate brachytherapy

Procedure

High dose-rate brachytherapy

Intensity-Modulated Radiation Therapy

Procedure

intensity-modulated radiation therapy

Primary outcomes

  1. 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

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2012
Study completion
2012
First posted
Oct 21, 2005
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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