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Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Degarelix
stereotactic body radiosurgery (SBRT)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Androgen Deprivation Therapy, Ultra-Hypofractionated SBRT, 16-1686

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Alliance MCI
  • Memorial Sloan Kettering Basking Ridge
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Bergen
  • Memorial Sloan Kettering Commack
  • Memorial Sloan Kettering Westchester
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Rockville Centre
  • Memorial Sloan Kettering Nassau
  • Lehigh Valley Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Degarelix in conjunction with stereotactic body radiosurgery

stereotactic body radiosurgery (SBRT)

Arm Description

Degarelix monthly for 6 months SBRT 8 Gy x 5

SBRT 8 Gy x 5

Outcomes

Primary Outcome Measures

number of patients with a positive biopsy
compare 2-year biopsy positivity rate of intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2017
Last Updated
August 16, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Ferring Pharmaceuticals, University of Texas Southwestern Medical Center, University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03056638
Brief Title
Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer
Official Title
Phase III Randomized Trial Comparing Short Course Androgen Deprivation Therapy and Ultra-Hypofractionated SBRT Versus SBRT Alone For Intermediate Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
August 16, 2023 (Actual)
Study Completion Date
August 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Ferring Pharmaceuticals, University of Texas Southwestern Medical Center, University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Androgen Deprivation Therapy, Ultra-Hypofractionated SBRT, 16-1686

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix in conjunction with stereotactic body radiosurgery
Arm Type
Experimental
Arm Description
Degarelix monthly for 6 months SBRT 8 Gy x 5
Arm Title
stereotactic body radiosurgery (SBRT)
Arm Type
Experimental
Arm Description
SBRT 8 Gy x 5
Intervention Type
Drug
Intervention Name(s)
Degarelix
Intervention Description
Degarelix monthly for 6 months
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiosurgery (SBRT)
Intervention Description
SBRT 8 Gy x 5
Primary Outcome Measure Information:
Title
number of patients with a positive biopsy
Description
compare 2-year biopsy positivity rate of intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.
Time Frame
2 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
prostate cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Zelefsky, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Alliance MCI
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Rockville Centre
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

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