Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05873192
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • ADT — DRUG
    Given by PO
  • Enzalutamide — DRUG
    Given by PO
  • Talazoparib — DRUG
    Given by PO
  • Degarelix — DRUG
    Given PO or given INJ
  • Luprolide — DRUG
    Given PO or given INJ

Study Details

To learn about the effectiveness of adding talazoparib to the standard of care treatment combination of androgen ablation therapy (hormone therapy, also known as ADT) and enzalutamide in patients with prostate cancer that has spread into the lymph nodes.

Key Dates

Start date
Jun 3, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ADT plus Enzalutamide plus Talazoparib
    Participant will recive ADT plus Enzalutamide for a total of 8 weeks. After about 8 weeks of ADT and Enzalutamide treatment, participant will begin taking Talazoparib

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Amado Zurita-Saavedra, MD
[email protected]
713-563-6966
Amado Zurita-Saavedra, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
M D Anderson Cancer Center· Houston, TX

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