High-Risk Metachronous Oligometastatic Prostate Cancer Trial

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06212583
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • niraparib/abiraterone acetate — DRUG
    Patients on Arm 2 to receive drug for 6 months
  • Stereotactic ablative radiation therapy (SABR) — RADIATION
    Both arms will receive SABR
  • Androgen deprivation therapy (ADT) — DRUG
    All ADT is provided as best prescribed for patient per their medical oncologist.

Study Details

The purpose of this research study is to compare the effects, good and/or bad, of using the standard of care treatment, hormonal therapy + Stereotactic Ablative Radiation (SABR) to the metastatic lesions, compared to standard of care and addition of 6-months of niraparib/abiraterone acetate combination pills and prednisone for participants with recurrent metastatic prostate cancer.

Key Dates

Start date
Apr 17, 2024
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Androgen deprivation therapy + Stereotactic ablative radiation
  • Active Comparator: Androgen deprivation therapy + Stereotactic ablative radiation + niraparib/abiraterone acetate

Primary Outcome Measure

PSA (Prostate Specific Antigen) evaluation at the 18-month progression of both treatment arms [ Time Frame: 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201-

Find similar trials in Baltimore, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Maryland Greenebaum Cancer Center· Baltimore, MD

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