TheranosticTrials.org

Clinical Trial · NCT05230251

Radioligand fOr locAl raDiorecurrent proStaTe cancER

Overview

Approximately 50-60% of men undergoing salvage brachytherapy post cancer recurrence to the prostate have the disease controlled at 5 years. This study aims to integrate a local treatment to the prostate (brachytherapy) with a treatment involving 177Lutetium (Lu)- Prostate-Specific Membrane Antigen (PSMA) therapy. Differently than brachytherapy, 177-Lutetium-PSMA is thought to have its effect not only to the cancer cells within the prostate, but also to cancer cells located elsewhere in the body. Thus, the idea here is that by adding 177Lutetium (Lu)- PSMA early in the course of treatment we may be able to inactivate potential metastatic cells outside the prostate, while the prostate cancer within this organ still treated by the combination of brachytherapy and 177-Lutetium-PSMA.

Sponsor

Sunnybrook Health Sciences Centre

Phase

Phase 1/2

Contacts

Glenn Bauman, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05230251

Drug / Compound

PNT2002

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

Eligibility

Inclusion

  • Adequate liver function: Total bilirubin \< 1.5 x upper limit of normal (ULN). Alanine aminotransferase (ALT) \< 3.5 x ULN
  • No contraindication to MRI
  • Men with prostate adenocarcinoma treated with prior primary radiotherapy at least 2 years previously
  • Biopsy confirmation of local recurrence within the prostate
  • Biochemical failure according to the Phoenix criteria(Roach et al. 2006)
  • Not currently experiencing genitourinary (GU) or gastrointestinal (GI) Grade 3 or higher toxicity associated with prior treatment
  • PSMA PET demonstrating isolated uptake (SUV\>3) within the prostate
  • Adequate marrow function (Absolute neutrophil count ≥ 1.5 x 109/L -Platelet count ≥ 100 x 109/L -Hemoglobin ≥ 90 g/L with no transfusions in the past 2 weeks)
  • No contraindication to therapy with high dose rate brachytherapy under general anaesthetic
  • No contraindication to treatment with \[177Lu-PSMA Agent\]

Exclusion

  • Consent not obtained or declines randomization
  • Does not meet eligibility criteria
  • Documented extraprostatic or distant recurrence on PSMA PET
  • Declines HDR salvage or not fit for HDR salvage procedure
  • Prior ablative radiotherapy to the prostate (prior HDR or LDR brachytherapy or SBRT/SABR to prostate)
  • Concurrent use of hormone therapy