Health TrialsbyHealthPanel

Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression

ConditionCastration Resistant Metastatic Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-90
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ECOG Performance status ≤2.

Age ≥18 years.

Histologically-confirmed adenocarcinoma of the prostate.

Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist).

Disqualifiers

Pain due to metastatic prostate cancer requiring treatment intervention with pain medication.

ECOG Performance status ≥3

Prior treatment with enzalutamide is prohibited.

Prior chemotherapy with docetaxel or cabazitaxel for castration resistant prostate cancer is prohibited.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Arm A: EnzalutamideExperimental treatment 1 intervention
Group B: Arm B: Sequential Testosterone and EnzalutamideExperimental treatment 3 interventions
Group C: Arm C: Variable Sequential Testosterone and EnzalutamideExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Clinical or Radiographic Progression free survival

Time from the date of the randomization to the date of first documented radiological progression per RECIST 1.1 for soft tissue or PCWG3 for bone lesions, or clinical progression or death, whichever occurs first.

Time frame
Up to 2 years

Secondary outcomes

1

Safety of cyclical parenteral testosterone as assessed by the revised National Cancer Institute Common Toxicity Criteria

Safety of cyclical parenteral testosterone in asymptomatic men with recurrent castrate resistant prostate cancer. Safety will be evaluated by adverse events as assessed by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0

Time frame
Up to 2 years
2

Prostate-Specific Antigen Response Rate

Number of participants achieving a Prostate-Specific Antigen decline ≥ 50% according to Prostate Cancer Working Group (PCWG2) criteria.

Time frame
Up to 2 years
3

Objective Response Rate as Determined by RECIST

Number of participants with partial (PR) or complete response (CR) as defined by response evaluation criteria in solid tumors (RECIST), where CR is a disappearance of all target lesions and PR is ≥30% reduction in the sum of the longest diameter of target lesions.

Time frame
Up to 2 years
4

Quality of Life as Assessed by FACIT Fatigue Scale

The Functional Assessment of Chronic Illness Therapy - Fatigue has a score range of 0-52 with higher scores indicating better quality of life.

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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