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New treatment option for Metastatic Castration-resistant Prostate Cancer
Official title Study With [225Ac]Ac-FL-020 in mCRPC Participants
ClinicalTrials.gov ID: NCT06492122
What this study is testing
What is [225Ac]Ac-FL-020?
[225Ac]Ac-FL-020 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic castration-resistant prostate cancer.
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
- The purpose of this study is to evaluate the safety, therapeutic effect, and pharmacokinetics of [225Ac]Ac-FL-020 in participants with metastatic castration-resistant prostate cancer (mCRPC).
- Phase 1: an early, usually small safety study
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, men only
You may be able to join if
- Histologically or cytologically confirmed metastatic CRPC.
- Age ≥ 18 years.
- Signed informed consent, and able and willing to comply with protocol requirements prior to any study procedures.
- Patients must have a life expectancy \>3 months.
- All patients are required to have one or more positive lesions detected by PSMA-PET/CT scan
You likely can't join if
- Patients with known brain metastases.
- Grade 3 Cystitis infective and non-infective.
- Severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study...
- More than 1 prior treatment with PSMA-targeted radioconjugate.
- Previous treatment with Actinium-225, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, or hemi-body irradiation or any other radionuclide...
- Radium-223 within 6 months prior to the first study treatment administration.
See the full eligibility criteria
- Histologically or cytologically confirmed metastatic CRPC.
- Age ≥ 18 years.
- Signed informed consent, and able and willing to comply with protocol requirements prior to any study procedures.
- Patients must have a life expectancy \>3 months.
- All patients are required to have one or more positive lesions detected by PSMA-PET/CT scan
- Documented progression of the disease based on the Investigator judgement
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Have a castrate serum testosterone \< 50 ng/dL or \<1.7 nmol/L. Patients must continue primary androgen deprivation with an LHRH analogue (agonist/antagonist) if they have not undergone bilateral orchiectomy.
- Have previously been treated with at least one of the following:
- Androgen receptor signaling inhibitor (such as enzalutamide).
- CYP 17 inhibitor (such as abiraterone acetate).
- Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. Note: In cases where patients are unwilling to undergo taxane therapy due to concerns regarding its potential...
- Adequate organ function as defined by:
- Absolute neutrophil count (ANC) ≥2 x 10\^9/L (2000/µL),
- Hemoglobin ≥9.0 g/dL,
- Platelets ≥90 x 10\^9/L (90 000/µL),
- Serum albumin \>3g/dL
- Aspartate aminotransferase (AST) ≤2.5 x ULN; alanine aminotransferase (ALT) ≤2.5 x ULN (AST, ALT ≤5 x ULN if liver metastases are present),
- Serum total bilirubin ≤1.5 x ULN (≤5 x ULN if liver metastases present)
- Creatinine clearance ≥60 mL/min calculated using a standard Cockcroft and Gault formula.
- Q wave to T wave (QT) interval corrected for heart rate (QTc) \<470 ms
- Patients with known brain metastases.
- Grade 3 Cystitis infective and non-infective.
- Severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the study treatment administration or may interfere with the...
- More than 1 prior treatment with PSMA-targeted radioconjugate.
- Previous treatment with Actinium-225, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, or hemi-body irradiation or any other radionuclide therapy except [177Lu]Lu-PSMA-617 and Radium-223.
- Radium-223 within 6 months prior to the first study treatment administration.
- Prior radioconjugate treatment within 6 weeks prior to first study treatment administration. Adverse events from prior radioconjugate treatment must be resolved or reduced to grade 1 prior to the first study treatment...
- More than 6 administrations of previous radioconjugate treatment.
- Any systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 6 weeks prior to the first study treatment administration. Patients on a stable...
- Evidence of superscan in the baseline bone scan.
- Any investigational agents within 6 weeks prior to the first study treatment administration.
- Radiotherapy: external beam radiotherapy that encompasses \>30% of bone marrow completed less than 6 weeks or focal radiation completed less than 2 weeks, prior to the first study treatment administration.
- Major surgery (not including placement of vascular access device or tumor biopsies) within 6 weeks prior to first dose of the study treatment, or no recovery from side effects of such intervention.
- Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
- Known hypersensitivity to the components of the study therapy or its analogs.
- Enrollment in another treatment clinical study.
- Any persistent xerostomia or dry eyes from previous treatment
- Persistent prior AEs \> Grade 1 from prior anti-cancer therapies.
- Significant cardiac disease, such as recent (within six months prior to first dose of the study treatment) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure...
- History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within 6 months prior to first dose of the study treatment.
- Known active infection requiring therapy, including known active infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or SARS-CoV-2
- Prior history of malignancy other than inclusion diagnosis within three years prior to first dose of the study treatment
- Known history of myelodysplastic syndrome.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- Stanford, California, United States
- Cleveland, Ohio, United States
- Charlottesville, Virginia, United States
- Brisbane, Australia
- Murdoch, Australia
- Sydney, Australia
- Beijing, China
- Shanghai, China
- Ankara, Turkey (Türkiye)
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 male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; Stanford, California, United States; Cleveland, Ohio, United States; Charlottesville, Virginia, United States; Brisbane, Australia and 5 more location(s). 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.