Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)

PEACE-6 Poor Responders is an international, multicenter, open-label, controlled, randomized, phase III trial to evaluate the efficacy and safety of 177Lu-PSMA-617 when administered on top of the ongoing standard systemic treatment compared to standard systemic treatment alone in patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC) who do not present with a satisfactory response characterized by a serum prostatic specific antigen (PSA) level of ≥ 0.2 ng/mL at 6 to 8 months after systemic treatment initiation for mHSPC (i.e. poor responders) in the absence of evidence of c

Trial Details

NCT ID
NCT06496581
Phase
PHASE3
Sponsor
UNICANCER
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • 177Lu-PMSA-617
  • Standard of Care
Locations (sample)
  • Angers, France|47.47156,-0.55202
  • Bordeaux, France|44.84124,-0.58046
  • Brest, France|48.39029,-4.48628
  • Caen, France|49.18585,-0.35912
  • Créteil, France|48.79266,2.46569

Key Eligibility Criteria

  • All of the following criteria must be met ahead of randomization to satisfy trial eligibility requirements:
  • Signed a written informed consent form prior to any trial specific procedures.
  • Note: In case of physical incapacitation, a trusted representative of their choice, which is not the Investigator or sponsor, can sign on the behal…
  • Aged ≥18 years old

For full eligibility, visit ClinicalTrials.gov.

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