XCancer

ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium

Description:

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.

Sponsor:

University College, London

Phase:

Phase 1/2

Contacts:

Gerhardt Attard (STUDY_DIRECTOR)

Trial Manager (CONTACT)

ncita.actinium@ucl.ac.uk

02076799274

Government Study Link:

NCT07414940 - Click here to see study on

ClinicalTrials.gov

PSMA

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

rhPSMA-10.1

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Inclusion
  • Prior treatment with at least one second-generation androgen receptor pathway inhibitor (ARPI)
  • PSMA-avid disease on screening PSMA-PET-CT scan
  • 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.
  • 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.
  • Histologically- or cytologically-confirmed diagnosis of prostate adenocarcinoma, which may include small cell or neuroendocrine features.
Exclusion
  • Prior radiotherapeutic treatment for metastatic prostate cancer (e.g. Radium-223) with the exception of 177Lu-PSMA. Note: prior radiotherapeutic treatment for other cancers is permitted (e.g. radioactive iodine for thyroid cancer).
  • Active metastatic central nervous system (CNS) disease, including leptomeningeal disease.