OncoMatch/Clinical Trials/NCT07142551
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
Is NCT07142551 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Testosterone cypionate and Luteinizing hormone-releasing hormone (LHRH) analogue for metastatic castration-resistant prostate cancer.
Treatment: Testosterone cypionate · Luteinizing hormone-releasing hormone (LHRH) analogue · Darolutamide — 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. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alternating therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: androgen deprivation therapy (surgical castration, LHRH agonist, LHRH antagonist)
Exception: neoadjuvant, concurrent and/or adjuvant AD therapy in the context of definitive radiation therapy if it was administered ≥ 1 year prior to recurrence
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 therapy in the context of definitive radiation therapy if it was administered ≥ 1 year prior to recurrence).
Cannot have received: androgen receptor pathway inhibitor (abiraterone, enzalutamide, darolutamide)
Exception: neoadjuvant, concurrent and/or adjuvant ARPI +/- ADT is permitted if given in the context of definitive radiation therapy if it was administered ≥ 1 year prior to development of metastatic disease
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 of definitive radiation therapy if it was administered ≥ 1 year prior to development of metastatic disease.
Cannot have received: chemotherapy
No prior treatment with chemotherapeutic regimens allowed.
Cannot have received: PSMA-targeted therapy (Pluvicto)
No prior treatment with Pluvicto or other PSMA-targeted agents is allowed.
Cannot have received: androgen receptor targeted investigational agent
No prior treatment with Androgen Receptor targeted investigational agents is permitted.
Lab requirements
Blood counts
ANC > 1000 cells/mm3; Platelet count > 100,000/mm3; Hemoglobin > 9 g/dL
Kidney function
Serum creatinine < 2.5x ULN
Liver function
Bilirubin < 2.5x ULN; AST (SGOT) and ALT (SGPT) < 2.5x ULN
Cardiac function
Abnormal cardiac function as manifested by NYHA 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 [excluded]
Acceptable liver function: Bilirubin < 2.5x ULN; AST (SGOT) and ALT (SGPT) < 2.5x ULN. Acceptable renal function: Serum creatinine < 2.5x ULN. Acceptable hematologic status: ANC > 1000 cells/mm3; Platelet count > 100,000/mm3; Hemoglobin > 9 g/dL. 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 [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center · Baltimore, Maryland
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