RecruitingPhase 1 / Phase 2

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

Phase I/II Study of CDK4/6 Inhibition With Abemaciclib to Upregulate PSMA Expression Prior to 177Lu-PSMA-617 Treatment in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Chemotherapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies, PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To assess changes in tumor microenvironment using ribonucleic acid (RNA) and whole exome sequencing by comparing biopsies obtained pre and post-combination treatment using the established institutional biopsy protocol (PSMA biopsy study)."
  • "To assess changes in PSMA expression in biopsies at the time of progression relative to pre-treatment biopsies using immunohistochemistry (IHC)."
  • "To describe patterns of progression following completion of treatment, including in patients with available 68Ga-PSMA-11 PET scans."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety, side effects, and best dose of abemaciclib given before 177Lu-PSMA-617, a treatment that carries radiation to cancer cells. It also tests whether this order helps kill more cancer cells. It is for adults with prostate cancer that has spread and keeps growing despite treatment to lower testosterone.

This phase I/II trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with prostate adenocarcinoma, a type of cancer confirmed by a tissue or cell sample.
  • Have cancer that has spread and is getting worse despite very low testosterone levels.
  • Have had at least one newer hormone treatment, such as abiraterone or enzalutamide. You must have had surgery to remove the testicles, be taking testosterone-lowering treatment, or both.
  • Have a PSMA PET scan showing at least one tumor with enough PSMA, a protein that the radiation treatment targets.
  • Be able to care for yourself and be out of bed for at least half the day. You must be expected to live more than 6 months.
  • Have blood counts and liver and kidney test results that meet study rules.
  • Be able to swallow pills and understand and sign the study consent form.
  • If you can father a child, agree to use effective birth control and not donate sperm during treatment and for at least 2 months afterward.

Who can't join

  • Have small cell or neuroendocrine prostate cancer, or a bone scan showing unusually high activity throughout the bones, called a “super scan.”
  • Have had a CDK4/6 blocker, the same type of drug as abemaciclib, or PSMA-targeted radiation treatment.
  • Have had radium-223 within 6 weeks or cancer medicine that treats the whole body within 3 weeks before joining. You also cannot be taking another experimental treatment.
  • Have had severe radiation side effects, still have radiation side effects, or have not recovered enough from other cancer treatment side effects. Hair loss and nerve damage are exceptions.
  • Have cancer in the brain or spinal cord unless it was treated, causes no symptoms, and needs no steroid treatment. Symptoms of pressure on the spinal cord also rule you out.
  • Have another serious illness or cancer that could make the study unsafe or affect the results. Examples include serious lung disease, major stomach or small bowel surgery, or bowel disease with ongoing diarrhea.
  • Have an active infection covered by the study rules, including a bacterial infection needing IV antibiotics. HIV and hepatitis B or C may be allowed if they meet the study’s treatment and virus-control rules.
  • Have a history of fainting caused by heart problems, certain dangerous heart rhythms, or sudden cardiac arrest.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Participants must have histologically or cytologically confirmed prostate cancer. Either fresh biopsy or archival tissue can be used for confirmation. 2. Age \>= 18 years. 3. Patients must have metastatic castration resistant prostate cancer (mCRPC) with progression based on Prostate Cancer Working Group 3 (PCWG3) criteria. 4. Patients must have adenocarcinoma histology. 5. Prior treatment with at least one novel hormonal agents (NHA) such as abiraterone acetate, enzalutamide, apalutamide, darolutamide etc. 6. Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L) 7. Patients must have a 68Ga-PSMA-11 PET scan with at least one PSMA-positive lesions (maximum standardized uptake value \[SUVmax\] greater than SUVmax of liver) as determined by nuclear medicine review prior to start of lead-in treatment with abemaciclib 8. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 9. Patients must have life expectancy of \> 6 months 10. Patients must have adequate organ function as outlined below and bone marrow reserve * 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 Exclusion Criteria: 1. Patients with small cell or neuroendocrine carcinoma histology. 2. Patients with a super scan seen in the baseline bone scan. Super scan refers to a bone scan with diffusely increased skeletal radioisotope uptake relative to soft tissue 3. Patients with prior treatment with CDK4/6 inhibitors 4. Patients with prior treatment with PSMA-targeted radioligand therapy. Patients with previous treatment with PSMA targeting therapies (Such as Chimeric antigen receptor T cells (CAR-T) or Bi-specific T-cell engagers (BiTEs) are eligible. 5. Patients treated with Radium-223 within 6 weeks prior to study entry. 6. Any systemic anti-cancer therapy within 3 weeks of study entry 7. Patients who have experienced significant radiation-related adverse events (AEs) from prior radiation treatment (\>= grade 3) or have experienced persistent radiation-related AEs that have not resolved by the time of study randomization 8. Patients with a history of central nervous system (CNS) metastases are ineligible unless they have received prior therapy (surgery, radiation therapy (RT), gamma knife) are asymptomatic, and not receiving corticosteroids for this indication. Head imaging is not required 9. Patients with symptoms of cord compression or impending cord compression 10. Patients with concurrent serious medical conditions as determined by primary investigator 11. Patients with other significant malignancies that are expected to alter life expectancy or interfere with disease assessment. Patients with adequately treated skin cancer, non-muscle-invasive bladder cancer and patients with prior history of malignancy who have been disease free for more than 2 years are eligible. Patients with history of in-situ/early stage melanoma will not be excluded 12. Patients who have not recovered from adverse events due to prior anti-cancer therapy to =\< grade 1 or baseline (other than alopecia or peripheral neuropathy) 13. Patients with serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea) 14. The patient has active systemic bacterial infection (requiring intravenous (IV) antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C (for example, hepatitis B surface antigen positive). Screening is not required for enrollment 15. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. 16. Patients currently receiving any other investigational therapeutic agents.

Study sites (1)

CA