Focal Radiation With Pulsed Systemic Therapy of Abiraterone, Androgen Deprivation Therapy (ADT), Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON)

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT04748042
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Abiraterone — DRUG
    Abiraterone 1000 mg by mouth per day for approximately 6 months.
  • Prednisone — DRUG
    Prednisone 5 mg by mouth per day for approximately 6 months.
  • External Beam Radiotherapy — RADIATION
    External beam radiotherapy, dose will depend on lesion location. Completed within 40 days of study start.
  • Androgen Deprivation Therapy (ADT) — BIOLOGICAL
    ADT by luteinizing hormone-releasing hormone (LHRH) agonist or antagonist for 6 months.
  • Olaparib — DRUG
    Olaparib tablets 300 mg by mouth twice a day for approximately 5 months.

Study Details

The purpose of this study is to assess the safety and effectiveness of radiation therapy with hormone therapy (ADT) and chemotherapy as an investigational study treatment for prostate cancer. This is a phase 2 study to deliver focal radiation with pulsed systemic therapy of Abiraterone, ADT and Lynparza (olaparib) in men with castration sensitive oligometastatic prostate cancer.

Key Dates

Start date
May 28, 2021
Status verified
Mar 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Abiraterone, ADT, Radiation and Olaparib
    Abiraterone, ADT, radiation to all metastases and Olaparib.

Primary Outcome Measure

Percentage of patients without treatment failure at 24 months [ Time Frame: 24 months after enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-

Find similar trials in Ann Arbor, MI

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Michigan Rogel Cancer Center· Ann Arbor, MI

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