A Multi-Center, Open-Label, Randomized Phase 2 Study of Copper Cu 64 PSMA I&T Injection in Patients With Histologically Proven Metastatic Prostate Cancer

Condition: Metastasis From Malignant Tumor of Prostate (Disorder)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05653856

Sponsor: Curium US LLC

Phase: Phase 2


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Patients with histologically proven prostate adenocarcinoma.
  2. Prior radical prostatectomy or radiation therapy with curative intent.
  3. Recurrence of disease defined as:
  4. Prior Radical Prostatectomy: PSA > 0.2 ng/mL, or
  5. Prior Radiation Therapy: 2 ng/mL rise in PSA over post-treatment nadir
  6. Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy.
  7. Age greater than or equal to 18 years.
  8. Able to understand and provide signed written informed consent.

Exclusion Criteria:

  1. Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway, unless subject has a rising PSA level.
  2. Body weight greater than 350 lb (158 kg).
  3. Investigational therapy within the past 30 days.
  4. Creatinine clearance (ClCr) less than 30 mL/min.
  5. Participants who are capable of fathering a child and who are unwilling to take precautions to prevent pregnancy.

View trial on ClinicalTrials.gov