RecruitingPhase 1/2

ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium

United Kingdom60 participantsStarted 2026-04-13

Plain-language summary

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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years at time of providing informed consent.
✓. Histologically- or cytologically-confirmed diagnosis of prostate adenocarcinoma, which may include small cell or neuroendocrine features.
✓. Castration-resistant prostate cancer, defined as a rising PSA despite surgical castration or ongoing medical castration, with serum testosterone ≤ 0.5ng/mL or \<1.7 nmol/L.
✓. Progressive mCRPC with rising PSA level, as defined by PCWG3 criteria, or by radiological progression, and must demonstrate a sequence of rising values above baseline at a minimum of 1-week intervals and PSA \> 1 ng/mL.
✓. PSMA-avid disease on screening PSMA-PET-CT scan
✓. Prior treatment with at least one second-generation androgen receptor pathway inhibitor (ARPI)
✓. Prior treatment with at least one but no more than two lines of taxane therapy for prostate cancer, or been deemed ineligible or refused taxane therapy on consultation with their treating physician.
✓. At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation of trial treatment. Anti-cancer treatment includes ARPIs and PARP inhibitors but excludes ADT (e.g. luteinising hormone releasing hormone (LHRH) analogue or gonadotropin-releasing hormone treatment), which should be continued. Prednisone up to 10 mg daily (or equivalent) is also permitted.

What they're measuring

Phase I incidence of dose-limiting toxicities (DLTs)

Timeframe: From time of IMP administration until completion of the dose-limiting toxicity period, which is 6 weeks.

Phase II anti-tumour response

Timeframe: From date of IMP administration until the occurrence of PSA nadir (for PSA50) or best radiographic response (for Objective Radiographic Response), monitored for a maximum of 5 years.

Trial details

NCT IDNCT07414940

SponsorUniversity College, London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-03-30

Contact for this trial

Trial Manager

02076799274 ncita.actinium@ucl.ac.uk

View on ClinicalTrials.gov More Metastatic Castration-resistant Prostate Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years at time of providing informed consent.
✓. Histologically- or cytologically-confirmed diagnosis of prostate adenocarcinoma, which may include small cell or neuroendocrine features.
✓. Castration-resistant prostate cancer, defined as a rising PSA despite surgical castration or ongoing medical castration, with serum testosterone ≤ 0.5ng/mL or \<1.7 nmol/L.
✓. Progressive mCRPC with rising PSA level, as defined by PCWG3 criteria, or by radiological progression, and must demonstrate a sequence of rising values above baseline at a minimum of 1-week intervals and PSA \> 1 ng/mL.
✓. PSMA-avid disease on screening PSMA-PET-CT scan
✓. Prior treatment with at least one second-generation androgen receptor pathway inhibitor (ARPI)
✓. Prior treatment with at least one but no more than two lines of taxane therapy for prostate cancer, or been deemed ineligible or refused taxane therapy on consultation with their treating physician.
✓. At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation of trial treatment. Anti-cancer treatment includes ARPIs and PARP inhibitors but excludes ADT (e.g. luteinising hormone releasing hormone (LHRH) analogue or gonadotropin-releasing hormone treatment), which should be continued. Prednisone up to 10 mg daily (or equivalent) is also permitted.

What they're measuring

Phase I incidence of dose-limiting toxicities (DLTs)

Timeframe: From time of IMP administration until completion of the dose-limiting toxicity period, which is 6 weeks.

Phase II anti-tumour response

Timeframe: From date of IMP administration until the occurrence of PSA nadir (for PSA50) or best radiographic response (for Objective Radiographic Response), monitored for a maximum of 5 years.

ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria