Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT07142551
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Testosterone cypionate — DRUG
    Intermittent intramuscular testosterone cypionate (T) at a dose of 400 mg every 4 weeks.
  • Luteinizing hormone-releasing hormone (LHRH) analogue — DRUG
    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.
  • Darolutamide — DRUG
    600 mg twice daily during the lead-in phase and on darolutamide cycle.

Study Details

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.

Key Dates

Start date
Mar 9, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2030
Completion
Jun 1, 2034

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lead-In Phase - ADT with an LHRH agonist or antagonist
    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. After this initial "lead-in" phase, patients who have clinical or radiographic progression or do not have at least a ≥50% decline in PSA will remain on combined androgen deprivation and discontinue study.
  • Experimental: Bipolar Androgen-based Therapy (BAT) Cycle
    Patients with ≥50% decline in PSA will discontinue combined androgen deprivation and will receive intermittent intramuscular testosterone cypionate (T) at a dose of 400 mg every 4 weeks for a total of 3 injections while on a BAT cycle (12 weeks).
  • Experimental: Darolutamide Cycle
    Patient will proceed to a cycle off BAT and start darolutamide alone at 600 mg twice daily for 12 weeks. Patients will continue with alternating cycles of BAT or darolutamide (without ADT) until clinical or radiographic progression.

Primary Outcome Measure

Percent of subjects free of Clinical or radiographic free progression [ Time Frame: 24 months from Day 1 (start of treatment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21205
Samuel Denmeade, MD
[email protected]
410-733-3232

Find similar trials in Baltimore, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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