TheranosticTrials.org

Clinical Trial · NCT06220188

PSMA-RLT in Biochemically Recurrent PCa

Overview

Prospective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng/ml after radical prostatectomy (RP) or PSA \> nadir + 2ng/ml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6 GBq in the second cycle) PSMA-RLT at 6-week intervals.

Sponsor

Medical University of Vienna

Phase

Phase 2

Contacts

Sazan Rasul, PhD (CONTACT)

sazan.rasul@meduniwien.ac.at

004314040058742

Shahrokh F. Shariat, Professor (CONTACT)

shahrokh.shariat@meduniwien.ac.at

004314040026150

ClinicalTrials.gov

NCT06220188

Drug / Compound

PSMA I&T

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

Eligibility

Inclusion

  • PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
  • Patients with biochemical recurrence after radical prostatectomy and radiotherapy with a PSA doubling-time (DT) of ≤ 12 months.

Exclusion

  • Complete urinary out-flow obstruction or severe unmanageable urinary incontinence.
  • Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study.