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New treatment option for Castration-Resistant Prostate Carcinoma
Official title Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT05113537
What this study is testing
What is Abemaciclib?
Abemaciclib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for castration-resistant prostate carcinoma.
Also referred to as Abemaciclib Oral, LY-2835219.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically or cytologically confirmed prostate cancer. Either fresh biopsy or archival tissue can be used for confirmation.
- Age \>= 18 years.
- Patients must have metastatic castration resistant prostate cancer (mCRPC) with progression based on Prostate Cancer Working Group 3 (PCWG3) criteria.
- Patients must have adenocarcinoma histology.
- Prior treatment with at least one novel hormonal agents (NHA) such as abiraterone acetate, enzalutamide, apalutamide, darolutamide etc.
You likely can't join if
- Patients with small cell or neuroendocrine carcinoma histology.
- Patients with a super scan seen in the baseline bone scan. Super scan refers to a bone scan with diffusely increased skeletal radioisotope uptake...
- Patients with prior treatment with CDK4/6 inhibitors
- Patients with prior treatment with PSMA-targeted radioligand therapy. Patients with previous treatment with PSMA targeting therapies (Such as...
- Patients treated with Radium-223 within 6 weeks prior to study entry.
- Any systemic anti-cancer therapy within 3 weeks of study entry
See the full eligibility criteria
Who can join
- Participants must have histologically or cytologically confirmed prostate cancer. Either fresh biopsy or archival tissue can be used for confirmation.
- Age \>= 18 years.
- Patients must have metastatic castration resistant prostate cancer (mCRPC) with progression based on Prostate Cancer Working Group 3 (PCWG3) criteria.
- Patients must have adenocarcinoma histology.
- Prior treatment with at least one novel hormonal agents (NHA) such as abiraterone acetate, enzalutamide, apalutamide, darolutamide etc.
- 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)
- 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...
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
- Patients must have life expectancy of \> 6 months
- 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...
- 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 =\ = 30 mL/min/1.73 m, calculated using the Cockcroft-Gault equation.
- Patient must be able to swallow oral medications
- Patients must have the ability to understand a written informed consent document, and the willingness to sign it
- Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- 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...
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- 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...
What rules you out
- Patients with small cell or neuroendocrine carcinoma histology.
- 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
- Patients with prior treatment with CDK4/6 inhibitors
- 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...
- Patients treated with Radium-223 within 6 weeks prior to study entry.
- Any systemic anti-cancer therapy within 3 weeks of study entry
- 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...
- 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...
- Patients with symptoms of cord compression or impending cord compression
- Patients with concurrent serious medical conditions as determined by primary investigator
- 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...
- 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)
- 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...
- 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...
- 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...
- Patients currently receiving any other investigational therapeutic agents.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.