TheranosticTrials.org

Clinical Trial · NCT04644822

Safety and Efficacy of [18F]PSMA-1007 Injection in Suspected Persistent or Recurrent Prostate Cancer.

Overview

This is a prospective, Phase 3 non-randomized, open label, multi-centre clinical trial to assess the safety and efficacy of \[18F\]PSMA-1007 Injection (investigational product or IP) in evaluating men with suspected persistent or recurrent disease (i.e., with biochemical failure), but with negative or equivocal conventional re-staging imaging (bone scan \[BS\] and computed tomography \[CT\] of abdomen and pelvis).

Sponsor

Unknown Organization

Phase

Phase 3

ClinicalTrials.gov

NCT04644822

Drug / Compound

PSMA-1007

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

Eligibility

Inclusion

  • Following primary ablative therapy to the prostate given with radical intent such as prior HIFU (high intensity focused ultrasound) or cryotherapy or other ablative energy therapy with biochemical failure as defined by the Stuttgart Criteria (nadir PSA + 1.2 ng/mL within 3 months prior to enrollment )
  • Not currently on systemic therapy (adjuvant or salvage) including androgen deprivation therapy
  • Karnofsky performance status 70 or better (ECOG 0, 1)
  • Suspected progressive or persistent disease after primary treatment for prostate cancer and biochemical failure (BF) with current management according to the following:
  • Following primary radiotherapy (with either brachytherapy, external beam radiotherapy or combined brachytherapy and radiotherapy) for localized disease, where BF is defined according to the Phoenix Definition, which is rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured within 3 months prior to enrollment greater than the nadir PSA + 2.0 ng/mL
  • Patient is medically suitable for salvage therapies
  • If PSA \> 10 ng/mL, conventional imaging consisting of bone scan and CT scan within 3 months prior to consent that is either negative or equivocal.
  • Prior primary treatment for prostate cancer with curative intent such as radical prostatectomy or radiotherapy for localized prostate cancer or other local or focal ablative therapy of the prostate
  • Following primary radical prostatectomy (with or without adjuvant or salvage radiotherapy to the prostate bed/pelvis), where BF is defined as rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured within 3 months prior to enrollment at \> 0.1 ng/mL

Exclusion

  • Undergoing ongoing occupational monitoring for radiation exposure
  • Prior PSMA PET scan within 6 months of enrolment