Clinical trial for Castration Resistant Metastatic Prostate Cancer
Official title Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression
ClinicalTrials.gov ID: NCT04363164
What this study is testing
What is Testosterone cypionate?
This is an investigational injectable medicine being studied as a potential treatment for castration-resistant metastatic prostate cancer. It is designed to raise testosterone levels in the body to a specific range while the patient remains on other cancer treatments.
Also referred to as Depo-Testosterone Injection.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether switching from continuous enzalutamide to a sequence of high‑dose testosterone and then enzalutamide improves outcomes compared to staying on enzalutamide alone.
- Who it's for
- Men with metastatic castration‑resistant prostate cancer who have no pain and whose cancer is still growing after prior hormone therapy.
- What's involved
- Participants will receive high‑dose testosterone for a set period, then start enzalutamide. They will have regular clinic visits and tests to monitor the cancer and side effects.
- Time commitment
- The study lasts about 12 months, with visits every few weeks to check health and cancer status.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90, men only
You may be able to join if
- 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 (\<50 ng/dl).
You likely can't join if
- 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.
- Requires urinary self-catheterization for voiding due to obstruction secondary to prostatic enlargement well documented to be due to prostate cancer...
- 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.
See the full eligibility 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 (\<50 ng/dl).
- Metastatic disease radiographically documented by CT or bone scan.
- 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
- Screening PSA must be ≥ 1.0 ng/mL.
- 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.
- No prior treatment with enzalutamide, apalutamide, darolutamide, or other investigational AR targeted treatment is allowed.
- Prior treatment with testosterone is allowed.
- Prior treatment with one chemotherapy regimen with docetaxel (≤ 6 doses) for hormonesensitive prostate cancer is allowed.
- Prior treatment with Provenge vaccine and 223Radium (Xofigo) is allowed if \>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.
- 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 \< 2.5 times ULN
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 (1.5 ×109/L)
- Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L)
- Hemoglobin ≥ 8 g/dL.
- At least 4 weeks since prior radiation or chemotherapy.
- Ability to understand and willingness to sign a written informed consent document.
- 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.
- 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).
- 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.
- 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...
- Active uncontrolled infection, including known history of HIV/AIDS or hepatitis B or C.
- 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.
- Patients receiving anticoagulation therapy with warfarin, rivaroxaban, or apixaban are not eligible for study. [Patients on enoxaparin eligible for study.
- Patients are excluded with prior history of a thromboembolic event within the last 12 months that are not being treated with systemic anticoagulation.
- Hematocrit \>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).
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Omaha, Nebraska, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Minneapolis, Minnesota, United States; Omaha, Nebraska, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.