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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 90 Years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 56 days
- Procedures mentioned: Injections, CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "Patients will continue to alternate one cycle of testosterone (2 injections) with one cycle of 56 days of enzalutamide."
- "Patients in Arm C will receive intramuscular injection with testosterone cypionate (T) at an FDA-approved dose of 400 mg every 28 days x 2 injections per cycle."
- "Patients with PSA progression (≥25% increase in PSA from baseline PSA on BAT cycle) will stop T injection and begin Enzalutamide."
- "Patients on T with initial with declining PSA decline PSA 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)based on PCWG3 criteria."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: 1. ECOG Performance status ≤2. 2. Age ≥18 years. 3. Histologically-confirmed adenocarcinoma of the prostate. 4. Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist). 5. Documented castrate level of serum testosterone (\<50 ng/dl). 6. Metastatic disease radiographically documented by CT or bone scan. 7. Must have had disease progression while on combination of abiraterone acetate plus ADT either given concurrently or sequentially based on: * PSA progression defined as an increase in PSA, as determined by 2 separate measurements taken at least 1 week apart And/ Or * Radiographic disease progression, based on RECIST 1.1 in patients with measurable soft tissue lesions or PCWG3 for patients with bone disease 8. Screening PSA must be ≥ 1.0 ng/mL. 9. Patients with soft tissue lesion amenable to biopsy must agree to biopsy collection pre-treatment and at a defined point on treatment to perform tumor tissue analysis. 10. No prior treatment with enzalutamide, apalutamide, darolutamide, or other investigational AR targeted treatment is allowed. 11. Prior treatment with testosterone is allowed. 12. Prior treatment with one chemotherapy regimen with docetaxel (≤ 6 doses) for hormonesensitive prostate cancer is allowed. 13. Prior treatment with Provenge vaccine and 223Radium (Xofigo) is allowed if \>4 weeks from last dose. 14. Patients must be withdrawn from abiraterone for ≥ 2 weeks. 15. 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. 16. Acceptable liver function: 1. Bilirubin \< 2.5 times institutional upper limit of normal (ULN) 2. AST (SGOT) and ALT (SGPT) \< 2.5 times ULN 17. Acceptable renal function: a. Serum creatinine \< 2.5 times ULN 18. Acceptable hematologic status: 1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 (1.5 ×109/L) 2. Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L) 3. Hemoglobin ≥ 8 g/dL. 19. At least 4 weeks since prior radiation or chemotherapy. 20. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: 1. Pain due to metastatic prostate cancer requiring treatment intervention with pain medication. 2. ECOG Performance status ≥3 3. Prior treatment with enzalutamide is prohibited. 4. Prior chemotherapy with docetaxel or cabazitaxel for castration resistant prostate cancer is prohibited. 5. Requires urinary self-catheterization for voiding due to obstruction secondary to prostatic enlargement well documented to be due to prostate cancer or benign prostatic hyperplasia (BPH). Patients with indwelling Foley or suprapubic catheter for obstructive symptoms are eligible. 6. Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g. femoral metastases with concern over fracture risk, severe and extensive spinal metastases with concern over spinal cord compression, extensive liver metastases). 7. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study. 8. Active uncontrolled infection, including known history of HIV/AIDS or hepatitis B or C. 9. Any condition or mental impairment that may compromise the ability to give informed consent, patient's safety or compliance with study requirements as determined by the investigator. 10. Patients receiving anticoagulation therapy with warfarin, rivaroxaban, or apixaban are not eligible for study. \[Patients on enoxaparin eligible for study. Patients on warfarin, rivaroxaban,or apixaban, who can be transitioned to enoxaparin prior to starting study treatments will be eligible\]. 11. Patients are excluded with prior history of a thromboembolic event within the last 12 months that are not being treated with systemic anticoagulation. 12. Hematocrit \>51%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure \[per Endocrine Society Clinical Practice Guidelines (34)\] 13. Patients allergic to sesame seed oil or cottonseed oil are excluded. 14. 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.
Study sites (6)
CA
- University of California, San Diego (UCSD) · San Diego, CA 92037Rana McKay, MD · Study contact · rmckay@health.ucsd.eduRana McKay, MD · Principal investigatorMore trials in San Diego
MA
- Dana-Faber Cancer Institute · Boston, MA 02215Jacob Berchuck, MD · Study contact · 919-452-4199 · jacob_berchuck@dfci.harvard.eduJacob Berchuck, MD · Principal investigatorMore trials in Boston
MD
- Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, MD 21287Samuel R. Denmeade · Study contact · 410-955-8875 · denmesa@jhmi.eduSamuel R. Denmeade · Principal investigatorMore trials in Baltimore
MN
- University of Minnesota · Minneapolis, MN 55455Emmanuel Antonarakis, MD · Study contact · anton401@umn.eduEmmanuel Antonarakis · Principal investigatorMore trials in Minneapolis
NE
- University of Nebraska Medical Center · Omaha, NE 68198Benjamin Teply, MD · Study contact · ben.teply@unmc.eduBenjamin Teply, MD · Principal investigatorMore trials in Omaha
WA
- University of Washington/Fred Hutchinson Cancer Center · Seattle, WA 98109Michael Schweizer, MD · Study contact · schweize@uw.eduMichael Schweizer, MD · Principal investigatorMore trials in Seattle