Actively Recruiting
ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium
Led by University College, London · Updated on 2026-05-08
60
Participants Needed
1
Research Sites
298 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
B
Blue Earth Therapeutics Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Advanced metastatic castration-resistant prostate cancer is a medical condition for which additional effective and tolerable treatments are urgently needed in order to improve patient outcomes and quality of life. The goal of this clinical trial is to learn more about Actinium (225Ac) radiohybrid prostate-specific membrane antigen-10.1 (rhPSMA-10.1) injection in men with prostate cancer that has spread and progressed after previous treatments, particularly after Lutetium-PSMA. Actinium (225Ac) rhPSMA-10.1 is an injectable radioactive medication that aims to attach to prostate cancer cells in the body and destroy them using ionising radiation. It is a new medication that has not yet been studied in humans. Participants will receive a dose of Actinium (225Ac) rhPSMA-10.1 every 6 weeks, to a maximum of 6 doses. They will be reviewed regularly by the trial researchers to monitor side effects and safety signals. A range of medication doses will be administered so that researchers can find out what doses of the medication are safe for men with prostate cancer. The trial will also aim to determine how effective this medication is for treating advanced prostate cancer.
CONDITIONS
Official Title
ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older at consent
- Histologically or cytologically confirmed prostate adenocarcinoma, including small cell or neuroendocrine features
- Castration-resistant prostate cancer with rising PSA despite surgical or ongoing medical castration (testosterone 60.5 ng/mL or <1.7 nmol/L)
- Progressive metastatic castration-resistant prostate cancer with rising PSA above 1 ng/mL or radiological progression
- PSMA-avid disease on screening PSMA-PET-CT scan
- Prior treatment with at least one second-generation androgen receptor pathway inhibitor
- Prior treatment with one or two lines of taxane therapy for prostate cancer, or ineligible/refused taxane therapy
- At least 4 weeks since last anti-cancer treatment (ARPIs and PARP inhibitors), excluding ongoing androgen deprivation therapy
- Prior 177Lu-PSMA-targeted radiopharmaceutical therapy (up to 6 cycles) with response, except for Phase I where first 3 participants per dose level may be 177Lu-PSMA naive; last 177Lu-PSMA treatment >10 weeks before enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Estimated life expectancy greater than 12 weeks
- Grade 61 xerostomia symptoms at enrollment
- Adequate bone marrow, kidney, and liver function
- Previous treatment-related toxicities resolved to Grade 61 except specified exceptions
- Use of adequate contraception
- Willing and able to provide informed consent
You will not qualify if you...
- Symptomatic spinal cord compression or signs of impending cord compression
- Active metastatic central nervous system disease, including leptomeningeal disease
- Received 177Lu-PSMA treatment within 10 weeks before enrollment
- Prior radiotherapy for metastatic prostate cancer except 177Lu-PSMA
- Blood transfusion or erythropoietin within 4 weeks before enrollment
- Major surgery within 12 weeks before enrollment
- Other current malignancy or relapse within 5 years except certain skin or bladder cancers
- Sjogren's disease or other conditions increasing risk of dry mouth
- Single kidney, kidney transplant, or nephrotoxic conditions risking kidney toxicity
- Severe urinary incontinence or conditions preventing safe radioactive urine disposal
- Structural kidney or renal tract disease affecting trial agent excretion unless corrected
- Significant ECG abnormalities during screening
- Serious concurrent conditions posing safety risk or impairing participation
- Radiation therapy within 2 weeks before enrollment
- Allergy to study medication or components
- Participation in another trial with ongoing investigational treatment
- Any psychological, social, or geographic factors hampering protocol compliance or safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
University College London Hospital
London, United Kingdom, WC1E 6BT
Actively Recruiting
Research Team
T
Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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