Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

Phase III Randomized Trial Comparing Short Course Androgen Deprivation Therapy and Ultra-Hypofractionated SBRT Versus SBRT Alone For Intermediate Prostate Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Degarelix; Radiation: stereotactic body radiosurgery (SBRT)

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • Baptist Alliance MCI
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Rockville Centre, New York, United States, 11570
      • Memorial Sloan Kettering Rockville Centre
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Ferring Pharmaceuticals; University of Michigan; University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Michael Zelefsky, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2017
• Primary Completion (Actual): August 16, 2023
• Study Completion (Actual): August 16, 2023

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Androgen Deprivation Therapy; Ultra-Hypofractionated SBRT; 16-1686
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 16-1686

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No