Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

NCT03056638 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 16-1686
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 10

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.

Conditions

Prostate Cancer

Keywords

Androgen Deprivation Therapy; Ultra-Hypofractionated SBRT; 16-1686

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Degarelix in conjunction with stereotactic body radiosurgery

EXPERIMENTAL

Degarelix monthly for 6 months SBRT 8 Gy x 5

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

stereotactic body radiosurgery (SBRT)

EXPERIMENTAL

SBRT 8 Gy x 5

Radiation: stereotactic body radiosurgery (SBRT)

Interventions

Degarelix DRUG

Degarelix monthly for 6 months

Degarelix in conjunction with stereotactic body radiosurgery

stereotactic body radiosurgery (SBRT) RADIATION

SBRT 8 Gy x 5

Degarelix in conjunction with stereotactic body radiosurgery; stereotactic body radiosurgery (SBRT)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Ferring Pharmaceuticals: collaborator
• University of Texas Southwestern Medical Center: collaborator
• University of Michigan: collaborator

Study Sites (10)

Baptist Alliance MCI

Miami, Florida, 33143, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Michael Zelefsky, MD
• Organization: Memorial Sloan Kettering Cancer Center

zelefskm@mskcc.org

212-639-6802

Study Officials

• Michael Zelefsky, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 17, 2017
• Study Start: March 28, 2017
• Primary Completion: August 16, 2023
• Study Completion: August 16, 2023
• Last Updated: August 28, 2024
• Results First Posted: August 28, 2024

Record last verified: 2024-08

Locations

US (10)