Ultra-hypofractionated Stereotactic Body Radiation Therapy with or without Short Course Degarelix in Treating Patients with Intermediate-Risk Prostate Cancer

Status: Active

Description

This randomized phase III trial studies how well ultra-hypofractionated stereotactic body radiation therapy alone works compared to ultra-hypofractionated stereotactic body radiation therapy and short course degarelix in treating patients with intermediate-risk prostate cancer. Ultra-hypofractionated stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using degarelix may fight prostate cancer by lowering the amount of testosterone the body makes. Giving ultra-hypofractionated stereotactic body radiation therapy and a short course of degarelix may work better in treating patients with prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Biopsy proven intermediate risk prostate cancer, which includes patients with any one of the following variables: * Gleason 7 disease * Prostate-specific antigen (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
  • Karnofsky performance status (KPS) >= 80%
  • Prostate size as determined on magnetic resonance imaging (MRI) to be < 90 cc; prostate size can be determined on computed tomography (CT) scan if MRI is not available
  • 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
  • Serum bilirubin =< 1.5 times the upper institutional limits of normal (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 (within 8 weeks of randomization)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (within 8 weeks of randomization)
  • Serum creatinine =< 1.5 x ULN (within 8 weeks of randomization)
  • Absolute neutrophil counts >= 1,500 cell/mm^3 (within 8 weeks of randomization)
  • Platelets >= 100,000 cells/mm^3 (within 8 weeks of randomization)
  • Hemoglobin value >= 9 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value >= 9 g/dL with blood transfusions are allowed) (within 8 weeks of randomization)

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 transurethral prostatic resection [TURP] or greenlight photoselective vaporization of the prostate [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

Locations & Contacts

Florida

Miami
Miami Cancer Institute
Status: Active
Contact: Marcio Augusto Fagundes
Phone: 786-596-2000

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Michael J. Zelefsky
Phone: 212-639-6802
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Michael J. Zelefsky
Phone: 212-639-6802
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Michael J. Zelefsky
Phone: 212-639-6802

New York

Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Michael J. Zelefsky
Phone: 212-639-6802
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Michael J. Zelefsky
Phone: 212-639-6802
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Michael J. Zelefsky
Phone: 212-639-6802
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Michael J. Zelefsky
Phone: 212-639-6802

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Approved
Contact: Dennis M. Sopka
Phone: 610-402-0700

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare 24-30 month post-stereotactic body radiation therapy (SBRT) prostate 12 core biopsy outcomes between intermediate risk patients treated with SBRT and short course androgen deprivation therapy (ADT) versus SBRT alone.

SECONDARY OBJECTIVES:

I. To assess whether the addition of 6 months of ADT with high dose SBRT decreases incident rates of biochemical failure and distant failure, or improves survival rate for intermediate risk prostate cancer patients compared to SBRT alone.

II. To assess the differences in short-term and long-term quality of life outcomes by comparing Expanded Prostate Cancer Index Composite (EPIC)-26, International Prostate Symptom Score (IPSS), and Short Form (SF)-12 survey results between intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive degarelix subcutaneously (SC) every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Following 3 months of treatment with degarelix, patients undergo ultra-hypofractionated SBRT every other day (QOD) for 5 fractions.

ARM 2: Patients receive ultra-hypofractionated SBRT as in Arm 1.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Michael J. Zelefsky

Trial IDs

Primary ID 16-1686
Secondary IDs NCI-2017-00741
Clinicaltrials.gov ID NCT03056638