TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) (NCT07190300)
TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer
🩺 Plain-English Summary (8th-Grade Level)
The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).
Who can join: Review the eligibility criteria below.
Location: Univ of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (31 Sites)
Showing the first 25 of 31 sites.
- Univ of Alabama at Birmingham — Birmingham, Alabama
- Uni Of Iowa Hospitals And Clinics — Iowa City, Iowa
- University of Kansas Cancer Center — Westwood, Kansas
- Wichita Urology Group PA — Wichita, Kansas
- Duke University Medical Center — Durham, North Carolina
- Medical University of South Carolina MUSC — Charleston, South Carolina
- Carolina Urologic Research Center — Myrtle Beach, South Carolina
- Huntsman Cancer Institute — Salt Lake City, Utah
- Novartis Investigative Site — Camperdown, New South Wales
- Novartis Investigative Site — Wollongong, New South Wales
- Novartis Investigative Site — Porto Alegre, Rio Grande do Sul
- Novartis Investigative Site — Montreal, Quebec
- Novartis Investigative Site — Guangzhou,
- Novartis Investigative Site — Créteil,
- Novartis Investigative Site — Lille,
- Novartis Investigative Site — Nantes,
- Novartis Investigative Site — Jena, Thuringia
- Novartis Investigative Site — Essen,
- Novartis Investigative Site — Hong Kong,
- Novartis Investigative Site — Budapest,
- Novartis Investigative Site — Budapest,
- Novartis Investigative Site — Szeged,
- Novartis Investigative Site — Rozzano, MI
- Novartis Investigative Site — Verona, VR
- Novartis Investigative Site — Seoul,
📞 Contact the Study Coordinator
Phone: (888) 669-6682
Email: novartis.email@novartis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05) — Ottawa, Ontario
- RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) — Washington D.C., District of Columbia
- Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer — Salt Lake City, Utah
- Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer — San Francisco, California
Explore by condition: All Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.