[225Ac]Ac-FL-020 for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Full-Life Technologies GmbH
Must be taking: LHRH analogue
Must not be taking: Radionuclide therapy
Disqualifiers: Brain metastases, Cystitis, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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).
What data supports the effectiveness of the treatment [225Ac]Ac-FL-020 for prostate cancer?
Research on a similar treatment, 225Ac-PSMA-617, shows it has a good anti-tumor effect in patients with metastatic prostate cancer, suggesting potential effectiveness for [225Ac]Ac-FL-020 as well.
12345How is the drug [225Ac]Ac-FL-020 different from other prostate cancer treatments?
[225Ac]Ac-FL-020 is unique because it uses a radioactive substance called Actinium-225 to target and kill prostate cancer cells specifically, which is different from traditional treatments that may not be as targeted. This approach, known as targeted alpha therapy, aims to minimize damage to healthy cells while effectively treating cancer.
34567Eligibility Criteria
This trial is for adults with metastatic castration-resistant prostate cancer (mCRPC) who have confirmed disease progression. Participants must have had prior treatments, including up to two taxane regimens and hormone therapies like abiraterone or enzalutamide. They should be in good physical condition (ECOG 0-1), have low testosterone levels maintained by medication or surgery, and show positive lesions on a PSMA-PET/CT scan.Inclusion Criteria
My cancer has gotten worse according to my doctor.
My prostate cancer has spread and was confirmed by a lab test.
I am 18 years old or older.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
Participants receive escalating doses of [225Ac]Ac-FL-020 to determine the maximum tolerated dose
4 weeks
Weekly visits for dose administration and monitoring
Cohort Expansion
Participants receive the determined dose of [225Ac]Ac-FL-020 to further evaluate safety and efficacy
28 days
Weekly visits for treatment and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 years
Regular imaging assessments and PSA level checks
Participant Groups
The study tests the safety and effectiveness of [225Ac]Ac-FL-020, a radioactive therapeutic agent for mCRPC. It also examines how the body processes this drug using blood and urine samples, alongside imaging techniques like SPECT/CT scans to monitor its distribution and effects within the body.
1Treatment groups
Experimental Treatment
Group I: [225Ac]Ac-FL-020Experimental Treatment5 Interventions
Treatment with \[225Ac\]Ac-FL-020 administered intravenously. 10 patients will also receive \[111In\]In-FL-020 for dosimetry purposes.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
City of Hope Medical CenterDuarte, CA
University of StanfordStanford, CA
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Who Is Running the Clinical Trial?
Full-Life Technologies GmbHLead Sponsor
References
Prevalence and Prognostic Implications of PSA Flares during Radium-223 Treatment among Men with Metastatic Castration Resistant Prostate Cancer. [2023]Radium-223 (Ra233) prolongs the survival of men with symptomatic bone-predominant metastatic castration-resistant prostate cancer (mCRPC). However, prostate-specific antigen (PSA) response patterns are not closely associated with Ra223 therapy outcomes. Herein, we sought to analyze the impact of Ra223-induced PSA flares on patient outcome. Using a retrospective cohort study of Ra223 treatment in four Ontario/Canada cancer centres, we identified 134 patients grouped into sub-cohorts according to distinct PSA response patterns: (i) initial PSA flare followed by eventual PSA decline; (ii) PSA response (≥30% PSA decrease within 12 weeks of treatment); and (iii) PSA non-response. We analyzed patient characteristics and outcome measures, including overall survival (OS), using the Kaplan-Meier method and log-rank testing. PSA flares were observed in 27 (20.2%), PSA responses in 11 (8.2%), and PSA non-responses in 96 (71.6%) patients. Amongst PSA flare patients, 12 presented with post-flare PSA decreases below baseline and 15 with PSA decreases below the flare peak but above baseline. Although only six flare patients achieved ≥30% PSA decreases below baseline, the median OS of all flare patients (16.8 months, 95% CI 14.9-18.7) was comparable to that of PSA responders and non-responders (p = 0.349). In summary, around 20% of mCRPC patients experience Ra223-induced PSA flares, whose outcome is similar to that of men with or without PSA responses. Further studies are needed regarding suitable biochemical surrogate markers of response to Ra223.
Clinicopathologic factors that influence prognosis and survival outcomes in men with metastatic castration-resistant prostate cancer treated with Radium-223. [2022]Label="BACKGROUND">In men with metastatic castration-resistant prostate cancer (mCRPC) with primarily bone metastases, radium-223 (223 Ra) improves overall survival (OS). However, the selection of 223 Ra is not guided by specific validated clinicopathologic factors, and thus outcomes are heterogeneous.
Three-year Safety of Radium-223 Dichloride in Patients with Castration-resistant Prostate Cancer and Symptomatic Bone Metastases from Phase 3 Randomized Alpharadin in Symptomatic Prostate Cancer Trial. [2022]In Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial, radium-223 versus placebo prolonged overall survival with favorable safety in castration-resistant prostate cancer patients with symptomatic bone metastases. Long-term radium-223 monitoring underlies a comprehensive safety and risk/benefit assessment.
Efficacy and Safety of 225Ac-PSMA-617-Targeted Alpha Therapy in Metastatic Castration-Resistant Prostate Cancer: A Systematic Review and Meta-Analysis. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">To conduct a meta-analysis of the efficacy and safety of 225Ac-PSMA-617 in the treatment of metastatic castration-resistant prostate cancer based on existing clinical evidence.
225Ac-PSMA-617 radioligand therapy of de novo metastatic hormone-sensitive prostate carcinoma (mHSPC): preliminary clinical findings. [2023]Label="PURPOSE"> 225Ac-PSMA-617 has demonstrated good anti-tumor effect as a treatment option for metastatic castration-resistant prostate cancer (mCRPC) patients. No study has previously assessed treatment outcome and survival following 225Ac-PSMA-617 treatment of de novo metastatic hormone-sensitive prostate carcinoma (mHSPC) patients. Based on the potential side effects that are known and explained to the patients by the oncologist, some of the patients refused the standard treatment and are seeking alternative therapies. Thus, we report our preliminary findings in a retrospective series of 21 mHSPC patients that refused standard treatment options and were treated with 225Ac-PSMA-617.
In-House Preparation and Quality Control of Ac-225 Prostate-Specific Membrane Antigen-617 for the Targeted Alpha Therapy of Castration-Resistant Prostate Carcinoma. [2022]Ac-225 labeled with prostate-specific membrane antigen (PSMA-617), a transmembrane glycoprotein which is highly expressed in prostate carcinoma cells, is presently being considered a promising agent of targeted alpha therapy for the treatment of patients suffering from metastatic castration-resistant prostate cancer. In the present study, we report an optimized protocol for the preparation of therapeutic dose of Ac-225 PSMA-617 with high yield and radiochemical purity (RCP).
Fracture risk and survival outcomes in metastatic castration-resistant prostate cancer patients sequentially treated with abiraterone acetate and RADIUM-223. [2021]Label="PURPOSE">To evaluate the fracture risk and survival outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) who received sequentially abiraterone acetate (AA) and radium 223 [223Ra]RaCl2 in the daily clinical practice.