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Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03056638
Collaborator
Ferring Pharmaceuticals (Industry), University of Texas Southwestern Medical Center (Other), University of Michigan (Other)
56
Enrollment
10
Locations
2
Arms
82.2
Anticipated Duration (Months)
5.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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
Phase 3

Study Design

Study Type:
Interventional
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 SBRTEligible 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 :
Mar 28, 2017
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Baptist Alliance MCI Miami Florida United States 33143
2 Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
3 Memorial Sloan Kettering Monmouth Middletown New Jersey United States 07748
4 Memorial Sloan Kettering Bergen Montvale New Jersey United States 07645
5 Memorial Sloan Kettering Commack Commack New York United States 11725
6 Memorial Sloan Kettering Westchester Harrison New York United States 10604
7 Memorial Sloan Kettering Cancer Center New York New York United States 10065
8 Memorial Sloan Kettering Rockville Centre Rockville Centre New York United States 11570
9 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
10 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT03056638
Other Study ID Numbers:
  • 16-1686
First Posted:
Feb 17, 2017
Last Update Posted:
Mar 2, 2022
Last Verified:
Mar 1, 2022
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

Study Results

No Results Posted as of Mar 2, 2022