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STARTAR - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if adding the study drugs apalutamide and docetaxel chemotherapy to a standard treatment for prostate cancer is more effective than the standard treatment alone.

What is the Condition Being Studied?

Prostate cancer with a rising PSA after prostatectomy

Who Can Participate in the Study?

Patients with prostate cancer who have had a prostatectomy and whose PSA has started to rise after surgery.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

Enter a screening period that includes a physical exam, imaging scans, blood draws, and quality-of-life surveys.

Once you've completed the screening period, you will
- Receive the study drugs apalutamide and docetaxel in addition to standard-of-care androgen deprivation therapy (ADT) and radiation therapy over a period of 36 weeks.
- Return to clinic at least every four weeks for exams, surveys and other procedures

- Once you finish the study treatment, you will have follow-up visits every 3 months for 3 years

Study Details

Full Title
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)
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00080868
NCT:NCT03311555
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698