A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR)

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

March 28, 2018

Primary Completion Date

December 22, 2022

Study Completion Date

December 22, 2022

Conditions
Prostate Cancer
Interventions
DRUG

Apalutamide

240mg tablet daily for 36 weeks

DRUG

Androgen deprivation

ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.

RADIATION

Salvage radiation therapy

On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks

DRUG

Docetaxel

About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.

Trial Locations (5)

10065

Weill Cornell Medical Center, New York

27157

Wake Forest Univesity, Winston-Salem

27518

Duke Cancer Center Cary, Cary

27710

Duke University Medical Center, Durham

68130

GU Research Network / Urology Cancer Center, Omaha

All Listed Sponsors
lead

Andrew J. Armstrong, MD

OTHER

NCT03311555 - A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR) | Biotech Hunter | Biotech Hunter