Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression

Part of paid clinical trials in San Diego, California.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT04363164
Phase
PHASE2
Status
Recruiting
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Conditions

  • Castration Resistant Metastatic Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Testosterone cypionate — DRUG
    Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
  • Enzalutamide — DRUG
    Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
  • Testosterone enanthate — DRUG
    Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.

Study Details

Asymptomatic men without pain due to prostate cancer progressing with metastatic CRPC after treatment with combination or sequential ADT + Abi will be treated on a randomized, open label study to determine if sequential treatment with high dose T and Enza will improve primary and secondary objectives vs. continuous Enza as standard therapy.

Key Dates

Start date
Aug 19, 2020
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Enzalutamide
    Patients randomized to Arm A will receive continuous therapy with standard dose Enzalutamide (160 mg oral daily).
  • Experimental: Arm B: Sequential Testosterone and Enzalutamide
    Patients in Arm B will receive intramuscular injection with testosterone cypionate (T) at a dose of 400 mg every 28 days x 2 (i.e. cycle 1). On Day 1 of cycle 2, patients will stop testosterone and begin enzalutamide 160 mg po q day for 56 days. Each cycle is 56 days. On Day 1 of cycle 3, patient will not take enzalutamide and will again receive injection of testosterone. Patients will continue to alternate one cycle of testosterone (2 injections) with one cycle of 56 days of enzalutamide.
  • Experimental: Arm C: Variable Sequential Testosterone and Enzalutamide
    Patients in Arm C will receive intramuscular injection with testosterone cypionate (T) at a dose of 400 mg every 28 days x 2 injections per cycle. Each cycle is 56 days. Patients with PSA progression will stop T injection and begin Enzalutamide. Patients on T with initial PSA decline will remain on high dose T for additional cycles of 2 injections until PSA progression occurs (≥25% increase in PSA from PSA nadir on current BAT cycle). These patients will then be started on Enzalutamide. Patients with PSA progression will stop Enzalutamide and will restart injections of T with 2 injections/cycle. Patients on enzalutamide with initial PSA decline after one 56-day cycle will continue on Enzalutamide until PSA progression occurs (≥25% increase in PSA from PSA nadir on current Enzalutamide cycle). These cycles of switching between T and Enza with onset of PSA progression will continue until clinical and/or radiographic progression occurs.

Primary Outcome Measure

Clinical or Radiographic Progression free survival [ Time Frame: Up to 2 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, San Diego (UCSD)San DiegoCalifornia92037
Rana McKay, MD
[email protected]
Rana McKay, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287
Samuel R. Denmeade
[email protected]
410-955-8875
Samuel R. Denmeade (PRINCIPAL_INVESTIGATOR)
Dana-Faber Cancer InstituteBostonMassachusetts02215
Jacob Berchuck, MD
[email protected]
919-452-4199
Jacob Berchuck, MD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55455
Emmanuel Antonarakis, MD
[email protected]
Emmanuel Antonarakis (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198
Benjamin Teply, MD
[email protected]
Benjamin Teply, MD (PRINCIPAL_INVESTIGATOR)
University of Washington/Fred Hutchinson Cancer CenterSeattleWashington98109
Michael Schweizer, MD
[email protected]
Michael Schweizer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By research site
University of California, San Diego (UCSD)· San Diego, CAJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDDana-Faber Cancer Institute· Boston, MAUniversity of Minnesota· Minneapolis, MNUniversity of Nebraska Medical Center· Omaha, NEUniversity of Washington/Fred Hutchinson Cancer Center· Seattle, WA

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