Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

June 21, 2018

Primary Completion Date

February 14, 2026

Study Completion Date

February 14, 2026

Conditions
Prostate Cancer
Interventions
DRUG

Apalutamide

240mg daily orally

DRUG

Abiraterone Acetate

1000mg daily orally

DRUG

Prednisone

5mg BID orally

PROCEDURE

Radical Prostatectomy

A laparoscopic, robotic-assisted, or open approach to RP is permitted at the discretion of the operating surgeon.

PROCEDURE

Extended Pelvic lymphadenectomy

To be performed concurrently with prostatectomy. Bilateral pelvic lymphadenectomy should include complete removal of all pelvic lymph nodes within the broad template described and includes the external iliac, hypogastric, obturator, and pre-sacral lymph nodes

DRUG

GnRH agonist/antagonist

Physician's choice, for a total duration not to extend beyond the treatment phase of the protocol or 10 months from the start of investigational agent(s)

RADIATION

Stereotactic Body Radiation Therapy

Subjects undergo SBRT in cycle 4, then salvage radiation therapy in cycles 7-8. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity

Trial Locations (11)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack

44195

Cleveland Clinic, Cleveland

60208

Northwestern University, Evanston

60637

University of Chicago, Chicago

02115

Dana Farber Cancer Institute, Boston

07920

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
collaborator

Dana-Farber Cancer Institute

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT03436654 - Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma | Biotech Hunter | Biotech Hunter