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Abemaciclib Before 177Lu-PSMA-617 for Metastatic Castrate Resistant Prostate Cancer

This study is testing the safety, side effects, and best dose of two drugs, abemaciclib and 177Lu-PSMA-617, when given together to treat metastatic castration-resistant prostate cancer. This is prostate cancer that has spread to other parts of the body and is no longer responding to hormone therapy. Abemaciclib works by blocking proteins that help cancer cells grow. 177Lu-PSMA-617 is a type of radiation therapy that targets and destroys cancer cells. The study aims to see how well this combination shrinks tumors and if it can lower prostate-specific antigen (PSA) levels. You may be able to join if you are 18 or older, have metastatic castration-resistant prostate cancer of the adenocarcinoma type, and meet other criteria. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Changes in tumor activity will be measured for up to 24 weeks.

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NCT05113537

Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Vadim S Koshkin
~30 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:AbemaciclibLutetium Lu 177-PSMA-617

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended phase 2 dose (Part A)
Measured over 6 weeks
+2 more outcomes measured

Conditions

Castration-Resistant Prostate Carcinoma
Metastatic Prostate Adenocarcinoma
Stage IV Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
Metastatic Castration-resistant Prostate Carcinoma
Metastatic Castration-resistant Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Vadim S Koshkin, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

UCSF Genitourinary Medical Oncology Recruitment
[email protected]
877-827-3222
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Eligibility criteria

Inclusion

White blood cell (WBC) \> 2.5
Absolute neutrophil count (ANC) \> 1.5
Hemoglobin (Hgb) \>= 8.0 \[Note- Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion\]
Platelets (Plt) \>= 100 x 10\^9/Liter (100,000/Microliter)
Total bilirubin =\< 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome =\< 2 ULN and direct bilirubin within normal limits is permitted
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT)) =\< 3 X institutional upper limit of normal (=\< 5.0 ULN for patients with liver metastases)
Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT)) =\< 3 X institutional upper limit of normal (=\< 5.0 ULN for patients with liver metastases)
Creatinine =\< 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m, calculated using the Cockcroft-Gault equation. 11. Patient must be able to swallow oral medications 12. Patients must have the ability to understand a written informed consent document, and the willingness to sign it 13. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial 14. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated 15. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load 16. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial 17. Patients with reproductive potential must agree to use effective contraception and to not donate sperm during the study and for at least 2 months following the last dose of study treatment. Effective method of contraception means male condom with spermicide, female condom with spermicide, diaphragm with spermicide, cervical sponge, or cervical cap with spermicide

What this trial measures

  • Recommended phase 2 dose (Part A)6 weeks

    If two or more patients in a cohort experience a dose-limiting toxicity (DLT), then the maximum tolerated dose (MTD)has been exceeded. The previous dose level will be considered the MTD and the recommended phase 2 dose. Per Investigator discretion, the recommended phase 2 dose/schedule of abemaciclib followed by 177Lu-PSMA-617 may be established in the absence of reaching MTD, based on the cumulative safety data of the treatment regimen.

  • Proportion of participants with DLTs (Part A)6 weeks

    Any non-hematologic, treatment-related adverse event (TRAE) Grade 3+, except of Grade 3 nausea,vomiting,diarrhea,constipation,fever,fatigue,skin rash,alopecia or non-clinically significant laboratory that resolves to Grade \<3 within 72 hours;Grade 4 thrombocytopenia lasting \>7 days;Grade 3+ thrombocytopenia with bleeding/requirement for platelet transfusion;Grade 4 neutropenia lasting \>7 days; Grade 3+ neutropenic fever;Grade 4+ anemia;TRAE requiring treatment discontinuation/delay of \>42 days;Failure to receive at least 66% of abemaciclib doses due to toxicity;Death not clearly due to underlying disease/extraneous causes;Hy's law;Grade 3+ nausea/vomiting/diarrhea \>72 hours;Grade 3+ fatigue \>7 days;Grade 3+ electrolyte abnormality \>72 hours, unless patient has clinical symptoms;All AEs of specified grades should count as DLTs except those that are clearly due to progression/extraneous causes.

  • Change in maximum standardized uptake value (SUVmax) across three lesions on gallium Ga 68 gozetotide (68Ga-PSMA-11) positron emission tomography (PET) scan (Part B)Up to 24 weeks

    The uptake in the three lesions with the highest SUVmax on the initial scan will be compared to SUVmax measurements in the same lesions on the PSMA PET scan following 14 days of priming treatment with abemaciclib