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Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03056638
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : May 23, 2019
Sponsor:
Collaborators:
Ferring Pharmaceuticals
University of Texas Southwestern Medical Center
University of Michigan
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that allows the physician to deliver more radiation dose in a single session. Because of this, the number of radiation sessions can be reduced from the typical 45-48 sessions, as in conventional daily session radiation, to 5 sessions given every other day over a week and a half. Giving the radiation at a higher dose during each treatment may be more effective in killing the prostate cancer cells than the standard way of using external radiation therapy where a small amount of radiation is given over many sessions.

Androgen Deprivation Therapy (ADT) or hormonal therapy is one of the methods to treat intermediate risk prostate cancer. This therapy works by reducing the level of testosterone and stopping them from affecting your cancer. The ADT used in this study is known as Degarelix. Degarelix is an approved medication that reduces the body's production of testosterone; this medication is usually given to all men with intermediate risk prostate cancer getting external radiation.

This study is a randomized study to find out whether combining stereotactic (also known as precision) radiation to the prostate cancer combined with a short course of Degarelix will result in a greater likelihood of killing the cancer in the prostate compared to stereotactic radiation therapy given alone. It has been shown that the combination of radiation with medications that interfere with testosterone production and its effects makes prostate cancer cells more sensitive to the radiation.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Degarelix Radiation: stereotactic body radiosurgery (SBRT) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible patients with intermediate risk disease will be randomized to ADT with SBRT versus SBRT alone. PSA and testosterone testing every 6 months, Biopsy 24-30 months after SBRT
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial Comparing Short Course Androgen Deprivation Therapy and Ultra-Hypofractionated SBRT Versus SBRT Alone For Intermediate Prostate Cancer
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Degarelix

Arm Intervention/treatment
Experimental: Degarelix in conjunction with stereotactic body radiosurgery
Degarelix monthly for 6 months SBRT 8 Gy x 5
Drug: Degarelix
Degarelix monthly for 6 months

Radiation: stereotactic body radiosurgery (SBRT)
SBRT 8 Gy x 5

Experimental: stereotactic body radiosurgery (SBRT)
SBRT 8 Gy x 5
Radiation: stereotactic body radiosurgery (SBRT)
SBRT 8 Gy x 5




Primary Outcome Measures :
  1. number of patients with a positive biopsy [ Time Frame: 2 years ]
    compare 2-year biopsy positivity rate of intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   prostate cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven intermediate risk prostate cancer, which includes patients with any one of the following variables:
  • Gleason 7 disease
  • PSA 10-20 ng/ml
  • Clinical T2b-T2c disease Note: Patients who only have radiographic evidence of T3 disease (i.e. extracapsular extension, or seminal vesical invasion radiographically) will not be excluded.
  • Serum testosterone ≥ 240 ng/dL determined within 2 months prior to enrollment
  • At least 4 weeks must have elapsed from major surgery
  • KPS ≥ 80%
  • Prostate size as determined on MRI to be < 90 cc. Prostate size can be determined on CT scan if MRI is not available.
  • 18 years of age or older
  • IPSS ≤ 20
  • Patient must be available for follow-up. After 2 years of follow-up following post-treatment biopsy, telephone-based follow-up will be acceptable
  • Laboratory test findings within 8 weeks of randomization:

    • Adequate hepatic function with serum bilirubin ≤ 1.5 times the upper institutional limits of normal (ULN), ALT and AST ≤ 2.5 x ULN. Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin
    • Adequate renal function with serum creatinine ≤ 1.5 x ULN
    • Adequate hematologic function with absolute neutrophil counts ≥ 1,500 cell/mm3 and platelets ≥ 100,000 cells/mm3 and hemoglobin value ≥ 9 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value ≥ 9 g/dL with blood transfusions are allowed)

Exclusion Criteria:

  • CT or MRI evidence of metastatic disease to the bone.
  • Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT
  • Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer (except for prior TURP or greenlight PVP which would be allowed)
  • History of another malignancy within the previous 3 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years
  • Patients with Crohn's disease or ulcerative colitis

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): NCT03056638


Contacts
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Contact: Michael Zelefsky, MD 212-639-6802 zelefskm@mskcc.org
Contact: Sean McBride, MD 212-639-5717

Locations
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United States, Florida
Baptist Alliance MCI Recruiting
Miami, Florida, United States, 33143
Contact: Marcio Fagundes, MD    786-596-2000      
United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Michael Zelefsky, MD    212-639-6802      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michael Zelefsky, MD    212-639-6802      
Principal Investigator: Michael Zelefsky, MD         
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Michael Zelefsky, MD    212-639-6802      
United States, Pennsylvania
Lehigh Valley Health Network Not yet recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Dennis Sopka, MD    610-402-0700      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Ferring Pharmaceuticals
University of Texas Southwestern Medical Center
University of Michigan
Investigators
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Principal Investigator: Michael Zelefsky, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03056638     History of Changes
Other Study ID Numbers: 16-1686
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Androgen Deprivation Therapy
Ultra-Hypofractionated SBRT
16-1686
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs