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)

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
Andrew J. Armstrong, MD
Study ID
NCT03311555
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Apalutamide — DRUG
    240mg tablet daily for 36 weeks
  • Androgen deprivation — DRUG
    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.
  • Salvage radiation therapy — RADIATION
    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
  • Docetaxel — DRUG
    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.

Study Details

The purpose of this study is to describe the rate of 3-year progression free survival in men with recurrent PSA-only disease after prostatectomy, who receive combined apalutamide (ARN-509) and standard ADT with salvage radiation therapy followed by docetaxel, ADT, and apalutamide, AND who have had testosterone recovery to \>100 ng/dl at 36 months. The hypothesis is that AR inhibition with apalutamide added to standard salvage external beam radiation with androgen deprivation therapy, as well as the addition of 6 cycles of docetaxel, will further prolong progression free survival.

Key Dates

Start date
Mar 28, 2018
Status verified
Feb 2024
Primary completion
Dec 22, 2022
Completion
Dec 22, 2022

Study Design

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

Arms

  • Experimental: Recurrent PSA-only non-metastatic prostate cancer
    Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.

Primary Outcome Measure

Progression-free Survival (PFS) at 36 Months (3 Years) [ Time Frame: up to 36 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
GU Research Network / Urology Cancer CenterOmahaNebraska68130-
Weill Cornell Medical CenterNew YorkNew York10065-
Duke Cancer Center CaryCaryNorth Carolina27518-
Duke University Medical CenterDurhamNorth Carolina27710-
Wake Forest UnivesityWinston-SalemNorth Carolina27157-

Find similar trials in Omaha, NE

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
GU Research Network / Urology Cancer Center· Omaha, NEWeill Cornell Medical Center· New York, NYDuke Cancer Center Cary· Cary, NCDuke University Medical Center· Durham, NCWake Forest Univesity· Winston-Salem, NC

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