177Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) With Bone Marrow Involvement and Cytopenia

NCT ID: NCT07025512

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-03
• Study Completion Date: 2029-06-30

Brief Summary

The purpose of the study is to examine the clinical and biological effects of 177Lu-PSMA-617 in mCRPC patients with cytopenia[s].

Conditions

Metastatic Castration Resistant Prostate Cancer; Cytopenia; Anemia; Thrombocytopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SingleArm

Treatment with 177Lu-PSMA-617

Group Type: EXPERIMENTAL

177Lu-PSMA-617

Intervention Type: DRUG

Given by IV

Interventions

177Lu-PSMA-617

Given by IV

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

1. Has primary bone marrow disorder (e.g. leukemia, myeloproliferative or myelodysplastic disorder)

2. Presence of iron deficiency or other hematological disorders that may cause anemia and cytopenia

3. Has participated in a study of an investigational agent or an investigational device within 4 weeks of the first dose of study therapy

4. Has received treatment with an approved systemic therapy within 2 weeks of dosing or has not yet recovered (i.e., grade ≤1 or baseline) from any acute toxicities attributed to the systemic therapy.

5. Has received radiation therapy or major surgery within 14 days of first administration of study drug.

6. Has received radiopharmaceutical agents in the past (e.g., Strontium-89, PSMA-targeted radioligand therapy)

7. Has received prior PSMA-targeting therapy

8. Another malignancy that is progressing or requires active treatment with the exception of non-melanoma skin cancer that has undergone potentially curative therapy

9. Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression

10. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection; or diagnosis of immunodeficiency

11. Has known allergy or hypersensitivity to study drugs

12. Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, Poly Adenosine Diphosphate-Ribose Polymerase (PARP) inhibitor, biological therapy, or investigational or anti-cancer therapy

13. Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that, in the opinion of the investigator, would impair study participation or cooperation

14. No active clinically significant cardiac disease is defined as any of the following:

a. History or current diagnosis of ECG abnormalities indicating a significant risk of safety for participants in the study, such as i. Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bi-fascicular block, Mobitz type II and third-degree AV block) ii. History of familial long QT syndrome or known family history of Torsades de Pointes

15. History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study

16. Symptomatic cord compression, unstable vertebral metastasis or clinical or radiologic findings indicative of impending cord compression

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bagi Jana, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bagi Jana, MD

Role: CONTACT

bjana@mdanderson.org

713-563-0670

Facility Contacts

Bagi Jana, MD

Role: primary

bjana@mdanderson.org

713-563-0670

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

2024-1690

Identifier Type: -

Identifier Source: org_study_id

NCI-2025-04173

Identifier Type: OTHER

Identifier Source: secondary_id