- ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium — Recruiting • Phase I • Oncology • NCT07414940.
- What is being tested: Actinium-225 (a targeted alpha particle therapy) in patients with advanced metastatic castration-resistant prostate cancer who have previously received Lutetium-177 treatment, evaluating efficacy and tolerability of this novel sequential therapeutic approach.
- Patient eligibility overview: Adults with metastatic castration-resistant prostate cancer who have progressed after Lutetium-177 therapy, meeting specific performance and organ function criteria, representing a heavily pre-treated population with limited remaining treatment options.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- Phase I 177Lu-PSMA requirement: The first 3 participants treated at each dose level may be 177Lu-PSMA treatment naïve or may have previously received 177Lu-PSMA treatment. Additional participants recruited at any dose level must have received prior 177Lu-PSMA treatment and had a response to therapy, as judged by the treating physician. Phase II 177Lu-PSMA requirement: All participants must have received prior 177Lu-PSMA and had a response to therapy, as judged by the treating physician. Inclusion Criteria: 1. Age ≥ 18 years at time of providing informed consent. 2. Histologically- or cytologically-confirmed diagnosis of prostate adenocarcinoma, which may include small cell or neuroendocrine features. 3. Castration-resistant prostate cancer, defined as a rising PSA despite surgical castration or ongoing medical castration, with serum testosterone ≤ 0.5ng/mL or 1 ng/mL. 5. PSMA-avid disease on screening PSMA-PET-CT scan 6. Prior treatment with at least one second-generation androgen receptor pathway inhibitor (ARPI) 7. 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. 8. At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.