Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer (NCT05828082)

🧪 Interventions in This Study

• Tuvusertib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Presence of SPOP mutations in prostate cancer cells, as indicated by Next Generation Sequencing (NGS)
2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm (\>= 2 cm) by chest x-ray or as \>= 10 mm (\>= 1 cm) with CT scan, MRI, or calipers by clinical exam
3. Castrate-range testosterone (=\< 50 ng/dL) after androgen deprivation therapy (ADT) or orchiectomy
4. Prior treatment with second generation anti-androgen (2GAA) and taxane- or lutetium-based therapy. More than one kind of prior treatment with 2GAA and taxane - or lutetium-based therapies is also acceptable
5. Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of M1774 in patients \< 18 years of age, children are excluded from this study
6. Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
7. Absolute neutrophil count \>= 1,500/mcL
8. Platelets \>= 100,000/mcL
9. Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
10. Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\]) or alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase \[SGPT\]) =\< 3 x institutional upper limit of normal (ULN)
11. Creatinine =\< 1.5 × ULN
12. Creatinine clearance \>= 60 mL/min

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (26 Sites)

Showing the first 25 of 26 sites.

• Mayo Clinic Hospital in Arizona — Phoenix, Arizona
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
• UM Sylvester Comprehensive Cancer Center at Aventura — Aventura, Florida
• UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida
• UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida
• Mayo Clinic in Florida — Jacksonville, Florida
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
• Memorial Hospital East — Shiloh, Illinois
• University of Kansas Cancer Center — Kansas City, Kansas
• University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas
• University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas
• Mayo Clinic in Rochester — Rochester, Minnesota
• Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri
• Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri
• Washington University School of Medicine — St Louis, Missouri
• Siteman Cancer Center-South County — St Louis, Missouri
• Siteman Cancer Center at Christian Hospital — St Louis, Missouri
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
• UT Southwestern Simmons Cancer Center - RedBird — Dallas, Texas
• UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas
• UT Southwestern/Simmons Cancer Center-Fort Worth — Fort Worth, Texas
• UT Southwestern Clinical Center at Richardson/Plano — Richardson, Texas
• University of Virginia Cancer Center — Charlottesville, Virginia
• University of Wisconsin Carbone Cancer Center - Eastpark Medical Center — Madison, Wisconsin

📞 Contact the Study Coordinator

Phone: (800) 664-4580

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.

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Explore by condition: All Castration-Resistant Prostate Carcinoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.