A phase II Salvage Trial of AR Inhibition with ADT and Apalutamide with Radiation therapy followed by docetaxel in men with PSA recurrent prostate cancer (PC) after radical prostatectomy (STARTAR).

Authors

Tian Zhang

Tian Zhang

Duke University Medical Center, Durham, NC

Tian Zhang , Bridget F. Koontz , Scott T. Tagawa , Himanshu Nagar , Rhonda L. Bitting , Bart Frizzell , Julia Rasmussen , Rhonda Wilder , Monika Anand , Carolyn Winters , Colleen Riggan , Aileen Lee , Patrick Healy , Yuan Wu , Megan Ann McNamara , Michael Roger Harrison , Daniel J. George , Andrew J. Armstrong

Organizations

Duke University Medical Center, Durham, NC, Sandra and Edward Meyer Cancer Center, New York, NY, New York-Presbyterian Hospital/Weill Cornell Medicine, New York, NY, Internal Medicine, Section on Hematology and Oncology, Winston Salem, NC, High Point Cancer Ctr, High Point, NC, Duke University School of Medicine, Durham, NC, Duke Cancer Institute, Durham, NC, Duke University, Durham, NC, Weill Cornell Medicine, New York, NY, Duke Cancer Institute, Duke University, Durham, NC, Department of Biostatistics and Bioinformatics, Duke Cancer Institute, Durham, NC, Duke Cancer Institute, Duke University Medical Center, Durham, NC, Duke University Cancer Institute, Durham, NC, Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC

Research Funding

Pharmaceutical/Biotech Company

Background: Androgen deprivation combined with salvage external beam radiation therapy (RT) have improved survival for patients (pts) with non-metastatic hormone naïve PC and PSA recurrence after radical prostatectomy (RP). Our recent STREAM trial showed addition of enzalutamide to RT and ADT had a 3-year progression free survival (PFS) of 53%. Adding effective PC treatments in this setting may further improve 3-year PFS. Methods: STARTAR is an investigator-initiated phase 2 trial for salvage treatment of biochemically recurrent PC following prostatectomy. Key inclusion criteria include histologic prostate adenocarcinoma, either Gleason 7 with T3/positive margin/1-4 positive lymph nodes or Gleason 8-10 disease, PSA relapse within 4 years of prostatectomy (minimum PSA 0.2 ng/mL to maximum PSA 4 ng/mL). Treatment involves ADT with apalutamide for 9 months, continue with with prostate bed +/- nodal RT at month 3, followed by 6 cycles of docetaxel 75mg/m2 IV every 3 weeks for 6 cycles. The primary endpoint of the study is 3-year PFS. With a one-sided alpha of 0.05 to improve 3-year PFS from 50% to 75%, we will have 92% power by enrolling 42 pts (including 10% dropout rate) based on the binomial test. Key secondary endpoints include 1, 2, and 3-year PSA recurrence rates with testosterone recovery, PSA PFS, PSA nadir, time to testosterone recovery, and safety of combination therapy. Quality of life will be assessed by EPIC questionnaire. As of February 2019, we have enrolled and treated 12 pts in this PCCTC trial. Accrual to the STARTAR trial is ongoing (NCT03311555). Clinical trial information: NCT03311555

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary (Prostate) Cancer

Track

Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track

Prostate Cancer - Advanced Disease

Clinical Trial Registration Number

NCT03311555

Citation

J Clin Oncol 37, 2019 (suppl; abstr TPS5097)

DOI

10.1200/JCO.2019.37.15_suppl.TPS5097

Abstract #

TPS5097

Poster Bd #

203b

Abstract Disclosures