Preliminary results of a 68 Ga-PSMA PET/CT prospective study in prostate cancer patients with occult recurrence: Diagnostic performance and impact on therapeutic decision-making

Prostate. 2019 Sep;79(13):1514-1522. doi: 10.1002/pros.23869. Epub 2019 Aug 17.

Abstract

Background: In this prospective study (NCT03443609), we investigated the impact of 68Ga-PSMA-11 PET-CT on the treatment plan and therapeutic response obtained for patients with prostate cancer (PCa) presenting a recurrence with a low rising PSA.

Methods: One hundred thirty hormone-naive (PSA < 1.5 ng/mL) patients were enrolled. All patients received radical treatment. PET images were recorded 1 and 2 hours after injection of tracer and interpreted by two independent nuclear physicians. Six months after treatment ended, a PSA assay was requested to evaluate the therapeutic efficacy of the treatment based on PSMA results.

Results: Data analysis for the first 52 included patients has been completed. 68Ga-PSMA-11-positive lesions were detected in 38/52 (73.1%) patients. Ninety-four lesions were detected as follows, 53/94 in lymph nodes (56.4%), 25/94 in bone (26.6%), and 12/94 into the prostate bed (12.7%). Detection rates were 58%, 81%, and 82% for serum PSA levels lower than 0.25 ng/mL, between 0.25 to ≤ 0.69 ng/mL and 0.70 ng/mL, respectively. As a result of the PSMA PET-CT, therapeutic management changed in 38/52 patients (73.1%). Patients had undetectable serum PSA levels after treatment guided by 68Ga-PSMA-11 PET-CT results in 10/52 (19.2%) cases and with a PSA decrease of over 60% in 18/52 (34.6%) patients.

Conclusion: Whilst our patient population presented a very low PSA level, preliminary results of the 68Ga-PSMA PET-CT study showed recurrence localization in more than half of the patients and this had a major clinical impact, as it resulted in treatment change in more than half of the patients and a significant decrease in PSA levels in a third of patients.

Keywords: 68Ga-PSMA; PET/CT; biochemical recurrence; impact on implemented management PSMA; prostate cancer.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Decision Making
  • Gallium Isotopes
  • Gallium Radioisotopes
  • Humans
  • Kallikreins / blood
  • Male
  • Membrane Glycoproteins*
  • Middle Aged
  • Neoplasm Recurrence, Local / blood
  • Neoplasm Recurrence, Local / diagnostic imaging*
  • Neoplasm Recurrence, Local / therapy*
  • Organometallic Compounds*
  • Positron Emission Tomography Computed Tomography / methods
  • Prospective Studies
  • Prostate-Specific Antigen / blood
  • Prostatic Neoplasms / blood
  • Prostatic Neoplasms / diagnostic imaging*
  • Prostatic Neoplasms / therapy*
  • Radiopharmaceuticals*

Substances

  • Gallium Isotopes
  • Gallium Radioisotopes
  • Membrane Glycoproteins
  • Organometallic Compounds
  • Radiopharmaceuticals
  • gallium 68 PSMA-11
  • KLK3 protein, human
  • Kallikreins
  • Prostate-Specific Antigen

Associated data

  • ClinicalTrials.gov/NCT03443609