Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

Conditions

• Newly Diagnosed Oligometastatic Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• radical prostatectomy — PROCEDURE
  surgical removal of the prostate
• stereotactic body radiotherapy — RADIATION
  Highly targeted radiation
• Leuprolide — DRUG
  Lowers serum testosterone
• apalutamide — DRUG
  antiandrogen
• abiraterone — DRUG
  Inhibits androgen synthesis

Study Details

This is a trial for patients with newly diagnosed metastatic prostate cancer with 5 or fewer sites of metastases. The trial involves surgery (removal of the prostate) or radiation to the prostate, six months of hormone therapy, and stereotactic body radiotherapy to the sites of metastasis.

Key Dates

Start date

Jul 1, 2018

Status verified

Jul 2025

Primary completion

Mar 31, 2024

Completion

Mar 31, 2024

Study Design

Enrollment

28 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Arm
  Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.

Primary Outcome Measure

Percentage of Participants With PSA<0.05ng/mL (Radical Prostatectomy) or PSA <Nadir+2ng/mL (Prostate Radiation) [ Time Frame: 6 months after recovery of testosterone ]

Locations (3)

Find similar trials in Long Beach, CA