Actively Recruiting
Study With [225Ac]Ac-FL-020 in mCRPC Participants
Led by Full-Life Technologies GmbH · Updated on 2026-01-29
50
Participants Needed
9
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study With [225Ac]Ac-FL-020 in mCRPC Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic castration-resistant prostate cancer.
- Age 18 years or older.
- Signed informed consent and willingness to follow study requirements.
- Life expectancy greater than 3 months.
- Presence of one or more positive lesions on PSMA-PET/CT scan.
- Documented disease progression based on investigator judgment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Castrate serum testosterone less than 50 ng/dL or less than 1.7 nmol/L; continue primary androgen deprivation if not surgically castrated.
- Prior treatment with at least one androgen receptor signaling inhibitor or CYP 17 inhibitor.
- Previous treatment with at least 1 but no more than 2 taxane regimens, with exceptions possible upon evaluation.
- Adequate organ function including specified blood counts, liver and kidney function, and QTc interval less than 470 ms.
You will not qualify if you...
- Known brain metastases.
- Grade 3 cystitis, infective or non-infective.
- Severe medical or psychiatric conditions increasing study risk or interfering with results.
- More than one prior PSMA-targeted radioconjugate treatment.
- Previous treatment with certain radionuclide therapies except specified ones.
- Radium-223 treatment within 6 months before study treatment.
- Radioconjugate treatment within 6 weeks prior with unresolved adverse events.
- More than 6 prior radioconjugate administrations.
- Systemic anti-cancer therapy within 6 weeks prior to study treatment, except stable bisphosphonate or denosumab.
- Superscan evidence on baseline bone scan.
- Investigational agents within 6 weeks prior.
- Recent external beam or focal radiotherapy as specified.
- Major surgery within 6 weeks prior without recovery.
- Symptomatic or impending spinal cord compression.
- Known hypersensitivity to study therapy components.
- Participation in another interventional clinical study.
- Persistent xerostomia or dry eyes from previous treatment.
- Persistent adverse events above Grade 1 from prior therapies.
- Significant recent cardiac disease or uncontrolled conditions.
- Recent thromboembolic or cerebrovascular events within 6 months.
- Active infections including HIV, hepatitis B or C, or COVID-19.
- History of other malignancies within 3 years except current diagnosis.
- Known myelodysplastic syndrome.
AI-Screening
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Trial Site Locations
Total: 9 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Chao Family Comprehensive Cancer Center
Irvine, California, United States, 92612
Actively Recruiting
3
University of Stanford
Stanford, California, United States, 94305
Actively Recruiting
4
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
5
Princess Alexandra Hospital
Brisbane, Australia
Actively Recruiting
6
Genesiscare Murdoch
Murdoch, Australia
Actively Recruiting
7
MacQuarie University Clinical Trial Unit
Sydney, Australia, NSW 2109
Actively Recruiting
8
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
9
Ankara Üniversitesi Tıp Fakültesi Cebeci Hastanesi Nükleer Tıp Anabilim Dalı
Ankara, Turkey (Türkiye), 06590
Actively Recruiting
Research Team
F
Full-Life Technologies
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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