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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 : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Colleen A. Lawton, Medical College of Wisconsin

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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radiation Therapy Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2060

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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).
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02177292


Contacts
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Contact: CCCTO 414-805-8900 cccto@mcw.edu
Contact: Colleen A Lawton, MD 414-805-4472 clawton@mcw.edu

Locations
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United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Colleen A Lawton, MD    414-805-4472    clawton@mcw.edu   
Contact: Allen Li, PhD    414-805-4400    ali@mcw.edu   
Principal Investigator: Colleen A Lawton, MD         
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Colleen A Lawton, MD Medical College of Wisconsin

Publications:
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Responsible Party: Colleen A. Lawton, Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02177292     History of Changes
Other Study ID Numbers: Prostate Cancer
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases