TheranosticTrials.org
Telix Pharmaceuticals

Clinical Trial · NCT05146973

A Single Arm, Phase 2 Trial of External Beam Radiation Therapy (EBRT) in Combination With 177Lu-DOTA-TLX591-CHO in Patients With Biochemically Recurrent Oligometastatic, Prostate Specific Membrane Antigen-Expressing Prostate Cancer

Overview

This is a phase II trial to evaluate the therapeutic efficacy of a radiolabelled PSMA-targeting antibody, 177Lu-TLX591, given in combination with external beam radiation therapy (EBRT) in patients with biochemically recurrent, oligometastatic, PSMA-expressing prostate cancer. TLX591 is being developed as a PSMA-targeting antibody to be radiolabelled with a therapeutic radiosotope for the treatment of PSMA-expressing tumours.

Sponsor

Telix Pharmaceuticals

Phase

Phase 2

Contacts

Julie Gisbon

julie.gibson@telixpharma.com

317-588-9700

Charlotte Hawkins, PhD

charlotte.hawkins@telixpharma.com

317-588-9700

ClinicalTrials.gov

NCT05146973

Drug / Compound

Isotope(s):
Target(s):

Eligibility

Inclusion

  • Biochemical relapse (serum >0.2ng/mL)
  • At least one pelvic nodal lesion >=5mm
  • Oligometastatic disease (<=5 metastatic lymph nodes)
  • Chemotherapy naive
  • Previous radical prostatectomy with curative intent

Exclusion

  • Bone or visceral metastases
  • Androgen deprivation therapy within 12 months of trial screening
  • History of any malignancy other than prostate cancer within 5 years of enrolment

Patient Education

Patient education not yet provided.

Publications

Locations

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