Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

Phase 3

Terminated

Conditions: Prostate Cancer

Interventions: Drug: Degarelix
Radiation: stereotactic body radiosurgery (SBRT)

Registration Number: NCT03056638

Lead Sponsor: Memorial Sloan Kettering Cancer Center

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 available

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 56

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Degarelix in conjunction with stereotactic body radiosurgery	Degarelix	Degarelix monthly for 6 months SBRT 8 Gy x 5
Degarelix in conjunction with stereotactic body radiosurgery	stereotactic body radiosurgery (SBRT)	Degarelix monthly for 6 months SBRT 8 Gy x 5
stereotactic body radiosurgery (SBRT)	stereotactic body radiosurgery (SBRT)	SBRT 8 Gy x 5

Primary Outcome Measures

Name	Time	Method
Number of Patients With a Positive Biopsy	2 years	compare 2-year biopsy positivity rate of intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (10): Memorial Sloan Kettering Basking Ridge
🇺🇸
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Bergen
🇺🇸
Montvale, New Jersey, United States
Memorial Sloan Kettering Monmouth
🇺🇸
Middletown, New Jersey, United States
Memorial Sloan Kettering Commack
🇺🇸
Commack, New York, United States
Memorial Sloan Kettering Westchester
🇺🇸
Harrison, New York, United States
Memorial Sloan Kettering Nassau
🇺🇸
Uniondale, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Memorial Sloan Kettering Rockville Centre
🇺🇸
Rockville Centre, New York, United States
Lehigh Valley Health Network
🇺🇸
Allentown, Pennsylvania, United States
Baptist Alliance MCI
🇺🇸
Miami, Florida, United States