TheranosticTrials.org

Clinical Trial · NCT03617588

68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer

Overview

This will be an open-labelled, single centre study in the UK. The study group will include 60 patients with three groups of patients being studied. Group A will consist of 20 patients who have been newly diagnosed with primary high risk prostate cancer and are scheduled for radical prostatectomy surgery. Group B will consist of 20 patients with a diagnosis of BCR with previous radical prostatectomy, and are being considered for radical salvage therapy. Group C will consist of 20 patients with a diagnosis of BCR with previous radical radiotherapy (but no surgery), and are being considered for radical salvage therapy.

Sponsor

Evergreen Theragnostics, Inc.

Phase

Phase 2

ClinicalTrials.gov

NCT03617588

Drug / Compound

THP-PSMA

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

Eligibility

Inclusion

  • No hormone therapy within the past three months.
  • Should not have received androgen-deprivation therapy within 3 months of screening.
  • No previous recurrences of PCa.
  • The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR on the basis of:
  • Post RP: two consecutive rises in PSA and final PSA \>0.lng/ml OR Post RP: three consecutive rises in PSA. This definition is also applicable to subjects with PSA persistence post RP (where the PSA fails to fall to undetectable levels).
  • Should not have received androgen-deprivation therapy within 3 months of screening.
  • Group A: Adenocarcinoma of the prostate gland suitable for radical Tx.
  • Suitable for surgical tx
  • No Hormone Therapy in last 3 monthsGroup C: PCa and a diagnosis of BCR, previously treated with radical radiotherapy, being considered for radical salvage therapy (with curative intent).
  • The subject is being considered for radical salvage therapy.
  • Gleason score 4+3 and above, or PSA \> 20 ng/mL or clinical stage \>T2C.
  • Increase in PSA level \~2.0 ng/ml above the nadir level after radiotherapy (RT) or brachytherapy, no previous recurrences of BCR.
  • Post RP: PSA doubling time of \~15 months OR PSA level 0.5 ng/ml.
  • Consideration for radical salvage therapy.
  • Adenocarcinoma of Prostate
  • No Hormone Therapy in last 3 monthsGroup B: PCa and a diagnosis of BCR, previously treated with radical prostatectomy, being considered for radical salvage therapy (with curative intent).
  • Original diagnosis of PCa, treated with radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR based on:

Exclusion

  • Group A:
  • Hip prostheses
  • Prior Tx for Prostate Tumours
  • Hormone Therapy in the last 3 months
  • Hip prostheses
  • eGFR \<20
  • Gleason \< 4+3
  • Hip prostheses
  • eGFR \<20Group C:
  • Hormone Therapy in the last 3 months
  • eGFR \<20Group B: