Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression
A Randomized Phase II Study Comparing Sequential High Dose Testosterone and Enzalutamide to Enzalutamide Alone in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer
About This Trial
- This clinical trial is testing whether alternating between high doses of testosterone and a standard cancer-fighting pill works better than taking the standard medicine by itself.
- It is for men whose prostate cancer has spread and started growing again after certain hormone therapies, but who do not have pain from their cancer.
- If you participate, you will be randomly assigned to receive either the alternating treatments or the standard daily medicine alone.
- Before considering this study, you should know that you cannot have taken the medication enzalutamide in the past, and you may need to agree to have small tumor tissue samples collected during the trial.
More Information
- 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.
Who Can Enroll
- Age Range: 18 - 90 years
- Gender: Male
- Who This Trial is For: This clinical trial is testing whether alternating between high doses of testosterone and a standard cancer-fighting pill works better than taking the standard medicine by itself.
Study Details
- Start Date: August 19, 2020
- Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Full Eligibility Criteria
Inclusion Criteria
- 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).
- Documented castrate level of serum testosterone (4 weeks from last dose.
- Patients must be withdrawn from abiraterone for ≥ 2 weeks.
- Attempts must be made to wean patients off prednisone prior to starting therapy. Patients who cannot be weaned due to symptoms may continue on lowest dose of prednisone achieved during weaning period.
- Acceptable liver function:
- Bilirubin < 2.5 times institutional upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) < 2.5 times ULN
- Acceptable renal function: a. Serum creatinine 51%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure [per Endocrine Society Clinical Practice Guidelines (34)]
- Patients allergic to sesame seed oil or cottonseed oil are excluded.
- Major surgery (eg, requiring general anesthesia) within 3 weeks before screening, or has not fully recovered from prior surgery (ie, unhealed wound). Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate.
Treatments
- Drug: Testosterone cypionate
- Drug: Enzalutamide
- Drug: Testosterone enanthate