Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment radiation therapy
Phase phase 2
Sponsor Medical College of Wisconsin
Start date June 2010
End date December 2016
Trial size 30 participants
Trial identifier NCT02177292, Prostate Cancer

Summary

The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
In this study we will deliver a high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).
radiation therapy Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).
A high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).

Primary Outcomes

Measure
Biochemical control
time frame: 3 years after registration of the last subject.

Secondary Outcomes

Measure
Incidence of adverse events as assessed by Common Toxicity Criteria of Adverse Events.
time frame: 3 years after registration of the last subject.
Metastasis free survival
time frame: 3 years after registration of the last subject.

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed, adenocarcinoma of the prostate - T1-2N0M0 with risk of pelvic lymph nodes involvement >25% by Roach formula [(2/3xPSA) + (Gleason Score - 6)x10], or any T3-4N0M0 - Karnofsky Performance Scale > 70 (Appendix II). - Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration (Appendix V). - No prior pelvic or prostate radiation or chemotherapy for any reason; induction hormonal therapy prior to registration is acceptable. - Patients must sign a study-specific consent form prior to registration. - No evidence of distant metastases (Bone scanning) Exclusion Criteria: - Clinical or pathological evidence of distant metastases (M1). - Radical surgery for carcinoma of the prostate - History of prior chemotherapy - History of prior pelvic radiation therapy - Children (age < 18).

Additional Information

Official title A Phase II Trial of High-Dose Pelvic Lymph Node IMRT( Intensity Modulated Radiation Therapy) and Hypofractionated Prostate IMRT for High Risk Prostate Cancer Patients
Principal investigator Colleen A Lawton, MD
Description In this study the treating physicians will deliver a high dose of radiation to pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). The study will evaluate the response of the cancer and side effects of radiation to pelvic lymph nodes and to the prostate. It is hoped that these newer technologies will: 1. allow a higher daily dose of radiation to the tumor and pelvic nodes 2. avoid nearby normal tissue and organs like the rectum and bladder 3. prevent the cancer from spreading or coming back
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medical College of Wisconsin.