ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
Active metastatic central nervous system (CNS) disease, including leptomeningeal disease.
Receipt of 177Lu-PSMA treatment within 10 weeks of trial enrolment.
Prior radiotherapeutic treatment for metastatic prostate cancer (e.g. Radium-223) with the exception of 177Lu-PSMA.
Trial design
Design model
Sequential
Treatments tested in this trial
Actinium (225Ac) rhPSMA-10.1
DrugDose will vary depending on trial phase and dose escalation/de-escalation stage
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Phase I dose escalation/de-escalation of Actinium (225Ac) rhPSMA-10.1Experimental treatment 1 intervention
Group B: Phase II cohort expansion at recommended Phase II doseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase I incidence of dose-limiting toxicities (DLTs)
Incidence of DLTs during the DLT observation period
Time frame
From time of IMP administration until completion of the dose-limiting toxicity period, which is 6 weeks.2
Phase II anti-tumour response
Proportion of patients with response to treatment, defined as either (or both) of: PSA reduction of ≥ 50% from baseline (PSA50), objective radiographic response as assessed by imaging using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) with Prostate Cancer Working Group 3 (PCWG3) recommendations
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University College, London
Lead sponsor
Blue Earth Therapeutics Ltd
Collaborator
Source ClinicalTrials.gov