Evaluating a new treatment for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety, tolerability, pharmacokinetics, and preliminary activity of RO7656594 in participants with advanced or metastatic prostate cancer. It will involve administering the treatment to eligible patients and monitoring their responses to determine effective dosing regimens. The study will also gather data on how the drug is processed in the body and its potential effectiveness against the disease.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
2. Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.
3. Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
4. Prior therapy with a taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen, unless otherwise specified.
5. For participants with a known pathogenic breast cancer gene 1 (BRCA1) or BRCA2 mutation: prior therapy with a poly (adenosine diphosphate (ADP)-ribose) polymerase (PARP) inhibitor, or are considered ineligible for treatment with a PARP inhibitor, if such therapy is approved and available.

Key Exclusion Criteria:

1. Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives (whichever is longer, not to exceed 28 days) prior to the first study treatment.
2. Treatment with any investigational agent within 28 days prior to the first study treatment.
3. Treatment with any previous AR protein degrader.
4. Untreated central nervous system (CNS) metastases or leptomeningeal disease.

Note: Other protocol specified inclusion/exclusion criteria may apply.

Where it's running

• HonorHealth
  Scottsdale, Arizona, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Sarah Cannon Research Institute @ Florida Cancer
  Orlando, Florida, United States Recruiting
• University of Illinois Hospital & Health Sciences System
  Chicago, Illinois, United States Recruiting
• SCRI Oncology Partners
  Nashville, Texas, United States Recruiting
• St Vincent's Hospital Sydney
  Darlinghurst, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: GO44537 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

  This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07650240

• GDC-1261 in advanced or metastatic prostate cancer

  This study tests GDC-1261 to see if it is safe and how it behaves in people with advanced or metastatic prostate cancer who have progressed on prior therapy.

  Recruiting at 6 sites Phase 1/2 Genentech, Inc. · Scottsdale, Arizona and 5 other locations · NCT07567846

• Detecting low PSMA prostate cancer using a special PET scan

  This study is testing a new type of PET scan to see if it can better detect advanced prostate cancer that has low PSMA levels or neuroendocrine features in patients.

  Recruiting at 2 sites Phase 1 Brigham and Women's Hospital · Boston, Massachusetts and 1 other locations · NCT06062745

• JANX013 and JANX007 combo in advanced prostate cancer

  A first-in-human study will test JANX013 together with JANX007 to see if this combination is safe and tolerable in adults with metastatic castration-resistant prostate cancer.

  Recruiting Phase 1 Janux Therapeutics · Nashville, Tennessee · NCT07813637

• PSMA PET-Staged Progression-Directed Radiotherapy for Limited Prostate Cancer Progression

  A real-world registry tests how well comprehensive progression-directed radiotherapy works for men with metastatic prostate cancer who show a small number of progressing lesions while on systemic therapy.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość, Lublin Voivodeship · NCT07691697

• Prostate Radiotherapy and Metastasis-Directed Therapy in Synchronous Oligometastatic Prostate Cancer

  This registry follows men with new, limited metastatic prostate cancer who receive targeted radiotherapy to the prostate and all visible metastases to see how they do over time in real-world care.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość, Lublin Voivodeship · NCT07686016

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.