Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

• ClinicalTrials.gov Identifier: NCT03056638
• Recruitment Status: Active, not recruiting
• First Posted: February 17, 2017
• Last Update Posted: January 29, 2021
• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Ferring Pharmaceuticals; University of Texas Southwestern Medical Center; University of Michigan
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Tracking Information

• First Submitted Date: February 15, 2017
• First Posted Date: February 17, 2017
• Last Update Posted Date: January 29, 2021
• Actual Study Start Date: March 28, 2017
• Estimated Primary Completion Date: February 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 16, 2017)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

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

• Condition: Prostate Cancer

Intervention

• Drug: Degarelix
  Degarelix monthly for 6 months
• Radiation: stereotactic body radiosurgery (SBRT)
  SBRT 8 Gy x 5

Study Arms

• Experimental: Degarelix in conjunction with stereotactic body radiosurgery
  Degarelix monthly for 6 months SBRT 8 Gy x 5
  Interventions:

  • Drug: Degarelix
  • Radiation: stereotactic body radiosurgery (SBRT)
• Experimental: stereotactic body radiosurgery (SBRT)
  SBRT 8 Gy x 5
  Intervention: Radiation: stereotactic body radiosurgery (SBRT)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 28, 2020): 56
• Original Estimated Enrollment (submitted: February 16, 2017): 120
• Estimated Study Completion Date: February 2022
• Estimated Primary Completion Date: February 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: prostate cancer

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03056638
• Other Study ID Numbers: 16-1686
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Responsible Party: Memorial Sloan Kettering Cancer Center
• Study Sponsor: Memorial Sloan Kettering Cancer Center

Collaborators

• Ferring Pharmaceuticals
• University of Texas Southwestern Medical Center
• University of Michigan

Investigators

• Principal Investigator: Michael Zelefsky, MD; Memorial Sloan Kettering Cancer Center

• PRS Account: Memorial Sloan Kettering Cancer Center
• Verification Date: January 2021