Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

• ClinicalTrials.gov Identifier: NCT03056638
• Recruitment Status: Completed
• First Posted: February 17, 2017
• Last Update Posted: August 18, 2023
• 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

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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 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
• Actual Primary Completion Date: August 16, 2023
• Actual Study Completion Date: August 16, 2023

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Florida

Baptist Alliance MCI

Miami, Florida, United States, 33143

United States, New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States, 07920

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States, 07748

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States, 07645

United States, New York

Memorial Sloan Kettering Commack

Commack, New York, United States, 11725

Memorial Sloan Kettering Westchester

Harrison, New York, United States, 10604

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, United States, 11570

Memorial Sloan Kettering Nassau

Uniondale, New York, United States, 11553

United States, Pennsylvania

Lehigh Valley Health Network

Allentown, Pennsylvania, United States, 18103

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Ferring Pharmaceuticals

University of Texas Southwestern Medical Center

University of Michigan

Investigators

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

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center 

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT03056638
• Other Study ID Numbers: 16-1686
• First Posted: February 17, 2017
• Last Update Posted: August 18, 2023
• Last Verified: August 2023

• 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:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases