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High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB) (SIB)

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ClinicalTrials.gov Identifier: NCT02177292
Recruitment Status : Recruiting
First Posted : June 27, 2014
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Colleen A. Lawton, Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE June 18, 2014
First Posted Date  ICMJE June 27, 2014
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE June 23, 2010
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
Biochemical control [ Time Frame: 3 years after registration of the last subject. ]
The primary goal of this study is to evaluate biochemical control assessed by PSA level.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2014)
  • Incidence of adverse events as assessed by Common Toxicity Criteria of Adverse Events. [ Time Frame: 3 years after registration of the last subject. ]
    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.
  • Metastasis free survival [ Time Frame: 3 years after registration of the last subject. ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)
Official Title  ICMJE 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
Brief 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).
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Radiation: Radiation Therapy
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).
Other Name: Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).
Study Arms  ICMJE Experimental: IMRT & IGRT Radiation Therapy
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).
Intervention: Radiation: Radiation Therapy
Publications * Kupelian PA, Willoughby TR, Reddy CA, Klein EA, Mahadevan A. Hypofractionated intensity-modulated radiotherapy (70 Gy at 2.5 Gy per fraction) for localized prostate cancer: Cleveland Clinic experience. Int J Radiat Oncol Biol Phys. 2007 Aug 1;68(5):1424-30. Epub 2007 Jun 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2060
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: CCCTO 414-805-8900 cccto@mcw.edu
Contact: Colleen A Lawton, MD 414-805-4472 clawton@mcw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02177292
Other Study ID Numbers  ICMJE Prostate Cancer
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Colleen A. Lawton, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Colleen A Lawton, MD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP