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

NCT07025512 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: 2024-1690NCI-2025-04173
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs).

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

SingleArm

EXPERIMENTAL

Treatment with 177Lu-PSMA-617

Drug: 177Lu-PSMA-617

Interventions

177Lu-PSMA-617 DRUG

Given by IV

SingleArm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Has primary bone marrow disorder (e.g. leukemia, myeloproliferative or myelodysplastic disorder)
• Presence of iron deficiency or other hematological disorders that may cause anemia and cytopenia
• Has participated in a study of an investigational agent or an investigational device within 4 weeks of the first dose of study therapy
• 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.
• Has received radiation therapy or major surgery within 14 days of first administration of study drug.
• Has received radiopharmaceutical agents in the past (e.g., Strontium-89, PSMA-targeted radioligand therapy)
• Has received prior PSMA-targeting therapy
• Another malignancy that is progressing or requires active treatment with the exception of non-melanoma skin cancer that has undergone potentially curative therapy
• Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression
• Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection; or diagnosis of immunodeficiency
• Has known allergy or hypersensitivity to study drugs
• Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, Poly Adenosine Diphosphate-Ribose Polymerase (PARP) inhibitor, biological therapy, or investigational or anti-cancer therapy
• 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
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Novartis: collaborator

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Cytopenia; Anemia; Thrombocytopenia

Interventions

Pluvicto

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Platelet Disorders

Study Officials

• Bagi Jana, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 17, 2025
• Study Start: August 3, 2025
• Primary Completion: May 4, 2026
• Study Completion: May 4, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-04

Locations

US (1)