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RECRUITING
NCT07142551
PHASE2

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

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.

Official title: Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response Via Modulation of ANdrogen Receptor (the SPIDERMAN Trial)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03-09

Completion Date

2034-06-01

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DRUG

Testosterone cypionate

Intermittent intramuscular testosterone cypionate (T) at a dose of 400 mg every 4 weeks.

DRUG

Luteinizing hormone-releasing hormone (LHRH) analogue

Eligible patients will initiate combined androgen deprivation therapy (ADT) with an LHRH agonist or antagonist (e.g. Eligard, Zoladex, Lupron, Orgovyx) in combination with standard dose darolutamide (600 mg twice daily) for a total of 6 months.

DRUG

Darolutamide

600 mg twice daily during the lead-in phase and on darolutamide cycle.

Locations (1)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States