Description:
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).
Title
- Brief Title: High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)
- 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
Clinical Trial IDs
- ORG STUDY ID:
Prostate Cancer
- NCT ID:
NCT02177292
Conditions
Purpose
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).
Detailed 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 Arms
Name | Type | Description | Interventions |
---|
IMRT & IGRT Radiation Therapy | 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). | |
Eligibility Criteria
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).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Biochemical control |
Time Frame: | 3 years after registration of the last subject. |
Safety Issue: | |
Description: | The primary goal of this study is to evaluate biochemical control assessed by PSA level. |
Secondary Outcome Measures
Measure: | Incidence of adverse events as assessed by Common Toxicity Criteria of Adverse Events. |
Time Frame: | 3 years after registration of the last subject. |
Safety Issue: | |
Description: | The time to the occurrence of severe late GU/GI toxicity is defined as the time interval from the tenth month after start of protocol treatment to the date of death. |
Measure: | Metastasis free survival |
Time Frame: | 3 years after registration of the last subject. |
Safety Issue: | |
Description: | Metastasis free survival in patients receiving dose escalation IG-IMRT (image-guided IMRT) to the pelvic lymph nodes with a simultaneous integrated boost to the prostate. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Medical College of Wisconsin |
Last Updated
February 1, 2017