Radiopharmaceuticals: TRC003 is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. TRC003 is a 225Ac-labeled novel molecule for targeted alpha therapy (TAT), which delivers alpha-particle radiation specifically to prostate cancer cells expressing PSMA. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits radiation to kill them.
Study summary
The purpose of this study is to evaluate safety and tolerability, pharmacokinetics （PK）, efficacy of TRC003 injection in patients with progressive PSMA-positive mCRPC who have been treated with androgen receptor pathway inhibitor (ARPI) or taxane-based chemotherapy. We plan to recruit 90 participants who will be randomly assigned to 1 of 3 dose cohorts (30 cases per dose cohort) with up to 6 cycles of treatment in this study.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Participants must have the ability to understand and sign ICF.
* Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate.
* Participants must have progressive mCRPC after treatment of ARPI or taxane-based chemotherapy.
* Participant must have been diagnosed with mCRPC with documented progressive disease.
* Participants must have prior orchiectomy and/or ongoing androgen-deprivation therapy with a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
* Participants must have one or more PSMA-positive lesions whose PSMA uptake (SUVmax) is more than 2 fold of the blood pool.
* Participants with an ECOG performance status of 0 - 2.
* Participants must have adequate organ function
* For participants who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal Investigator during the study and for 6 months after last investigational product administration.
Exclusion Criteria:
* Participants with mixed histology of prostate cancer (e.g., neuroendocrine).
* Any FDG-positive and PSMA-negative target lesions.
* Any investigational agents and other concurrent chemotherapy, targeted therapy, biologic agents, immunotherapy, radioligand therapy (androgen-deprivation therapy excepted) within 28 days or 5 half-lives prior to day of administration, whichever is longer.
* Previous treatment with any conventional external beam radiotherapy including hemi-body radiation within 6 weeks before enrollment.
* Previous bone-targeted therapy cannot be taken with a stable dose within 4 weeks before enrollment.
* Known hypersensitivity to the components of the study therapy or its analogs.
* Transfusion for the sole purpose of making a participant eligible for study inclusion within 28 days before administration.
* A superscan as seen in the baseline bone scan.
* Concurrent serious (as determined by the Investigator) medical conditions.
* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment.
Primary outcome measure(s)
Incidence and severity of AEs and SAEs — From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months. Adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) by monitoring adverse events, laboratory tests, vital signs, Electrocardiogram(ECG).
Prostate Specific Antigen response (PSA50) — About 12 months. The percentage of participants who achieved ≥ 50% decrease from baseline at 12 weeks after the first administration or later.
Trial sites (2)
Facility
City
Region
Status
Cancer Hospital, Chinese Academy of Medical Sciences, Shanxi Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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