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New treatment option for Metastatic Castration-resistant Prostate Cancer
Official title Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
ClinicalTrials.gov ID: NCT07142551
What this study is testing
What is Testosterone cypionate?
Testosterone cypionate is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for metastatic castration-resistant prostate cancer.
Also referred to as Depo-Testosterone.
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 objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Age ≥ 18 years
- Performance status ≤2.
- Documented histologically confirmed adenocarcinoma of the prostate.
- Baseline PSA ≥1.0 ng/ml.
- No prior androgen deprivation therapy (i.e. surgical castration LHRH agonist, LHRH antagonist) as treatment for biochemically recurrent or metastatic...
You likely can't join if
- No prior treatment with chemotherapeutic regimens allowed.
- No prior treatment with Pluvicto or other PSMA-targeted agents is allowed.
- No prior treatment with Androgen Receptor targeted investigational agents is permitted.
- Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere...
- Evidence of disease that, in the opinion of the investigator, would put the patient at risk from testosterone therapy (e.g. femoral metastases with...
- Requires urinary self-catheterization for voiding due to obstruction secondary to prostatic enlargement well-documented to be due to prostate cancer...
See the full eligibility criteria
- Age ≥ 18 years
- Performance status ≤2.
- Documented histologically confirmed adenocarcinoma of the prostate.
- Baseline PSA ≥1.0 ng/ml.
- No prior androgen deprivation therapy (i.e. surgical castration LHRH agonist, LHRH antagonist) as treatment for biochemically recurrent or metastatic disease (may have received neoadjuvant, concurrent and/or adjuvant AD...
- No prior treatment with ARPI (abiraterone, enzalutamide, darolutamide) for biochemically recurrent or metastatic prostate cancer. Neoadjuvant, concurrent and/or adjuvant ARPI +/- ADT is permitted if given in the context...
- Prior focal radiation treatment (e.g. SABR, Cyberknife) for oligometastatic disease is permitted if \> 6 months. Patients must have evidence of metastatic disease in non-irradiated sites to be eligible for study.
- Evidence of rising PSA on two successive dates \> 2 weeks apart.
- Evidence of metastatic disease on CT scan or bone scan performed with six weeks of screening.
- Patients with bone pain due to prostate cancer are eligible for trial but must be pain free at the end of the 6-month lead-in phase to be eligible to receive subsequent BAT.
- Patients with soft tissue lesions amenable to biopsy must agree to baseline and 6 months tumor biopsies to enroll in study.
- 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 \< 2.5 times ULN
- Acceptable hematologic status:
- Absolute neutrophil count (ANC) \> 1000 cells/mm3 (1.0 ×109/L)
- Platelet count \> 100,000 platelet/mm3 (100 ×109/L)
- Hemoglobin \> 9 g/dL.
- Ability to understand and willingness to sign a written informed consent document.
- No prior treatment with chemotherapeutic regimens allowed.
- No prior treatment with Pluvicto or other PSMA-targeted agents is allowed.
- No prior treatment with Androgen Receptor targeted investigational agents is permitted.
- 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...
- Evidence of disease that, in the opinion of the investigator, would put the patient at risk from testosterone therapy (e.g. femoral metastases with concern over fracture risk, spinal metastases with concern over spinal...
- 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...
- Active uncontrolled infection.
- 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 or Coumadin are not eligible for study. Patients on non-coumadin anticoagulants (Lovenox, Eliqis, Xarelto, etc.) are eligible for study. Patients on Coumadin who...
- 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 as determined by the treating physician within 3 weeks before screening, or has not fully recovered from prior surgery (i.e., unhealed wound). Note: people with planned procedures (minor surgery with local...
- Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within the last five years prior to enrollment in the study.
- Inability to provide informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, 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 - 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.