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Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

Short Title: CCTG-PR26


Enrollment Status: Recruiting

NCT #: NCT06592924

Specialty Area: Oncology

Condition Studied: Prostate Adenocarcinoma

Age Groups: Adult; Older Adult

Phase: III


Study Information

Summary / Purpose

The purpose of this study is to compare the usual treatment of hormone treatment (ADT and ARPI) alone to using docetaxel plus the usual treatment for patients with metastatic castration sensitive prostate cancer (mCSPC) who have a suboptimal PSA response after 6-12 months of androgen-targeting therapy.

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Adult males 18+ years of age
  • Confirmed diagnosis of adenocarcinoma of prostate or a PSA >100 ng/ml (100 ug/L) and metastatic disease at diagnosis
  • Must have a PSA of ≥2.0 ng/ml (2.0 ug/L) prior to starting hormone treatment (ADT)

What's Involved

Participation in the study will include:
  • Random assignment to receive either the usual hormone treatment alone, or the usual hormone treatment plus docetaxel chemotherapy given intravenously (IV)
  • Continuing hormone treatment with androgen deprivation therapy (ADT), which blocks the body's production of male hormones
  • Continuing an androgen receptor pathway inhibitor (ARPI) taken by mouth, which may be abiraterone, enzalutamide, apalutamide, or darolutamide

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.