Actively Recruiting
A Multi-site, Prospective, Open-label Phase I/II Trial of Actinium (225Ac) rhPSMA 10.1 to Evaluate Safety and Anti-tumour Activity in Men With Metastatic Castrate-resistant Prostate Cancer (mCRPC) Including Those Who Have Previously Responded to Lutetium-PSMA
Led by University College, London · Updated on 2026-05-08
60
Participants Needed
1
Research Sites
39 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
This trial focuses on men with advanced metastatic castration-resistant prostate cancer (mCRPC), a condition where prostate cancer continues to grow despite treatments that lower testosterone. Researchers aim to learn more about Actinium (225Ac) rhPSMA-10.1, a new injectable radioactive drug designed to target and destroy prostate cancer cells, especially in men whose cancer has progressed despite prior treatments including Lutetium-PSMA. The study includes Phase I and Phase II components to evaluate safety and anti-tumor activity. Participants will receive Actinium (225Ac) rhPSMA-10.1 every six weeks, up to six doses. Phase I will determine safe dosage levels through dose escalation or de-escalation, including some men who have not previously received Lutetium-PSMA. Phase II will treat men who have responded to Lutetium-PSMA using the dose established in Phase I. Throughout the trial, participants will have regular check-ups, blood tests, and scans to monitor treatment effects and safety. During the study, men will be closely monitored weekly by trial doctors, sometimes remotely, to assess tolerance and side effects. Blood tests and imaging scans will be done regularly to evaluate cancer response. Some participants will provide blood samples for genetic analysis. After completing treatment, participants will remain in follow-up to study long-term effects. The main outcomes measured include dose-limiting toxicities in Phase I and anti-tumor response in Phase II, with monitoring lasting up to five years.
CONDITIONS
Brief 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
- Histologically or cytologically confirmed prostate adenocarcinoma, including small cell or neuroendocrine features
- Castration-resistant prostate cancer with rising PSA despite surgical or medical castration, serum testosterone 64 0.5ng/mL or <1.7 nmol/L
- Progressive metastatic castration-resistant prostate cancer with rising PSA level or radiological progression according to PCWG3 criteria
- PSMA-avid disease on screening PSMA-PET-CT scan
- Prior treatment with at least one second-generation androgen receptor pathway inhibitor
- Prior treatment with 1 to 2 lines of taxane therapy or ineligible/refused taxane therapy
- At least 4 weeks or 5 half-lives since last anti-cancer treatment (excluding ongoing ADT and permitted prednisone use)
- Prior treatment with 177Lu-PSMA therapy with response, except for first 3 Phase I participants who may be Lutetium-PSMA naïve; last 177Lu-PSMA treatment must be >10 weeks before enrollment
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Estimated life expectancy greater than 12 weeks
- Grade 64 1 xerostomia symptoms at enrollment
- Adequate bone marrow, renal, and hepatic function
- Resolution of prior treatment toxicities to Grade 64 1, except specified exceptions
- Adequate contraception for participant and partner
- Willing and able to provide written 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
- Receipt of 177Lu-PSMA treatment within 10 weeks prior to enrollment
- Prior radiotherapeutic treatment for metastatic prostate cancer other than 177Lu-PSMA
- Receipt of blood transfusions or erythropoietin agents within 4 weeks prior to enrollment
- Major surgery within 12 weeks prior to enrollment
- Current other malignancy or malignancy diagnosed/relapsed within past 5 years except specified exceptions
- Sjogren's disease or other conditions increasing risk of xerostomia
- Single kidney, renal transplant, nephrotoxic conditions or therapies increasing renal toxicity risk
- Severe urinary incontinence or conditions preventing safe radioactive urine disposal
- Structural kidney or renal tract diseases affecting trial agent excretion unless corrected
- Significant abnormalities on screening ECG
- Concurrent serious conditions posing safety risks or impairing participation
- Radiation therapy within 2 weeks prior to enrollment
- Hypersensitivity to investigational product or its components
- Current participation in another trial with ongoing investigational treatment
- Psychological, familial, sociological, or geographical factors hampering compliance or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 36 weeks (six doses at six-week intervals)
Participants receive Actinium (225Ac) rhPSMA-10.1 treatment every six weeks, up to a maximum of six doses if they tolerate treatment well and their prostate cancer does not worsen.
Weekly visits with a trial doctor for monitoring, sometimes conducted remotely; CT and bone scans every 12 weeks; regular blood tests
Duration - Up to 5 years
After completing treatment, participants are asked to remain on follow-up to help understand any long-term impacts of the treatment.
Visits for long-term monitoring as scheduled by the trial team
Trial Site Locations
Total: 1 location
1
University College London Hospital
London, United Kingdom, WC1E 6BT
Actively Recruiting
Research Team
T
Trial Manager
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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