Trial intelligence / Profile preview

Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

NCT03298087Phase 2

Key facts

Status: Completed
Start: Jul 2018
Primary completion: Mar 2024
Countries: 1
Sponsor: VA Office of Research & Development
Modality: Peptides, Orthosteric Ligands

Drugs: apalutamideabirateroneleuprolide
Conditions: prostate cancer (PCa)

Overview

Phase 2, open-label, single-arm trial of apalutamide, abiraterone and leuprolide in prostate cancer (PCa), sponsored by VA Office of Research & Development. Primary endpoint: Percentage of Participants With PSA<0.05ng/mL or PSA <Nadir+2ng/mL. Started Jul 2018; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Experimental Arm
Radical prostatectomy or radiation, SBRT, and 6 months of leuprolide, abiraterone, and apalutamide.

Who it enrols

Adult males with newly diagnosed oligometastatic prostate adenocarcinoma (1-5 visible metastases, no visceral metastases), fit for radical prostatectomy, SBRT, and ADT, with adequate organ function and no history of seizures or severe cardiovascular events.

Endpoints

Primary

Percentage of Participants With PSA<0.05ng/mL or PSA <Nadir+2ng/mL6 months after recovery of testosterone

Secondary

Time to Biochemical Progressionup to 5 years
Time to Radiographic Progressionup to 5 years
Time to Initiation of Additional Antineoplastic Therapyup to 5 years
Prostate Cancer Specific Survivalup to 5 years
Patient Reported Outcomes as Assessed by Functional Assessment of Cancer Therapy - Prostate ScaleEvery 3 months up to 21 months
Number of Participants With Treatment-related Adverse Eventsup to 5 years

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