Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056638
• Other study ID #: 16-1686
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2017
• Est. completion date: August 16, 2023

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
Degarelix monthly for 6 months

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

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Baptist Alliance MCI	Miami	Florida
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York
United States	Memorial Sloan Kettering Nassau	Uniondale	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Ferring Pharmaceuticals, University of Michigan, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center