![MP18-10: A PHASE 1, OPEN-LABEL, MULTI-CENTER, NON-RANDOMIZED STUDY OF [F-18]SMS-5368 POSITRON EMISSION TOMOGRPHY IN PROSTATE CANCER PATIENTS WITH BIOCHEMICAL RECURRENCE AND NEGATIVE CONVENTIONAL IMAGING](https://img.swapcard.com/?u=https%3A%2F%2Fapp.swapcard.com%2Fapi%2Fsession-banner-placeholder%2FUGxhbm5pbmdfMTg0ODAwMQ%3D%3D%3Fts%3D2024-05-04%252000%3A48%3A43%26timezone%3DUS%252FCentral%26lng%3Den-US%26isMounted%3Dfalse%26themeMode%3Dlight&q=0.8&m=fit&h=720)
MP18-10: A PHASE 1, OPEN-LABEL, MULTI-CENTER, NON-RANDOMIZED STUDY OF [F-18]SMS-5368 POSITRON EMISSION TOMOGRPHY IN PROSTATE CANCER PATIENTS WITH BIOCHEMICAL RECURRENCE AND NEGATIVE CONVENTIONAL IMAGING
Friday, May 3, 2024 3:30 PM to 5:30 PM · 2 hr. (US/Central)
302B
Abstract
Information
Full Abstract and Figures
Author Block
Paul A Hatcher, Knoxville, TN, Stephen H Culp, Charlottesville, VA, Carl C von Gall, Dustin R Osborne, Yitong Fu, William B Smith, Abhi Moolupuri*, Dustin L Whitaker, Knoxville, TN
Introduction
[F-18]SMS-5368 is a novel positron-emitting radiopharmaceutical imaging tracer developed at Siemens Molecular Imaging (SMI) for in vivo imaging of active Prostatic Specific Membrane Antigen (PSMA) in human tumors. Pharmacologically, [F-18]SMS-5368 contains a urea scaffold and mimics PSMA’s natural substrate N-acetylated-aspartyl-glutamic acid. Additionally, this agent’s hepatobiliary excretion pathway may enable improved cancer detection within the prostate fossa, an area traditionally obscured by renally excreted radiotracers. Early data suggests a favorable diagnostic imaging profile. We present preliminary results of the phase 1 study of prostate cancer patients with biochemical recurrence (BCR) and negative conventional imaging.
Methods
22 patients with BCR and no evidence of regional or metastatic disease on CT or bone scan were selected to undergo [F-18]SMS-5368 PET/CT. BCR was defined per AUA/ASTRO guidelines. PSA values were obtained within 1 week of scan. Scans were interpreted by a local and central radiologist.
Results
22 men (aged 61 - 88) met inclusion criteria. 17 men had prior radical prostatectomy while 5 men had prior radiation therapy. PSA ranged from 0.3 to 37.4 ng/ml. Median PSA was 0.6 ng/ml. 100% of [F-18]SMS-5368 PET/CT scans yielded positive results. Patients were scanned up to 190 minutes with complete absence of tracer excretion into the urinary system. Sites of uptake included prostate bed/prostate (6, median PSA 1.2), pelvic lymph nodes (8, median PSA 0.4), bone (5, median PSA 0.5), soft tissue (1, median PSA 6.4) and lymph nodes/bone (2, median PSA 1.45). Spinal metastases were noted in 5 of 7 bony metastasis patients. 15 patients demonstrated locoregional recurrence while 7 patients exhibited distant metastasis. There was 100% agreement between local and central radiologist interpretation of PET/CT scans after consensus reading. There were no adverse events.
Conclusions
[F-18]SMS-5368 PET/CT detected prostate cancer recurrence at low PSA levels in men with BCR and negative conventional imaging. [F-18]SMS-5368 PET/CT scans were reproducibly interpreted by both local and central radiologists. The lack of [F-18]SMS-5368 tracer excretion into the urinary system may improve detection of local recurrence, better identifying candidates for salvage therapy. This preliminary data suggests high sensitivity for recurrent prostate cancer detection, however further clinical investigation is warranted.
Source Of Funding
Siemens Molecular Imaging funded this research
Author Block
Paul A Hatcher, Knoxville, TN, Stephen H Culp, Charlottesville, VA, Carl C von Gall, Dustin R Osborne, Yitong Fu, William B Smith, Abhi Moolupuri*, Dustin L Whitaker, Knoxville, TN
Introduction
[F-18]SMS-5368 is a novel positron-emitting radiopharmaceutical imaging tracer developed at Siemens Molecular Imaging (SMI) for in vivo imaging of active Prostatic Specific Membrane Antigen (PSMA) in human tumors. Pharmacologically, [F-18]SMS-5368 contains a urea scaffold and mimics PSMA’s natural substrate N-acetylated-aspartyl-glutamic acid. Additionally, this agent’s hepatobiliary excretion pathway may enable improved cancer detection within the prostate fossa, an area traditionally obscured by renally excreted radiotracers. Early data suggests a favorable diagnostic imaging profile. We present preliminary results of the phase 1 study of prostate cancer patients with biochemical recurrence (BCR) and negative conventional imaging.
Methods
22 patients with BCR and no evidence of regional or metastatic disease on CT or bone scan were selected to undergo [F-18]SMS-5368 PET/CT. BCR was defined per AUA/ASTRO guidelines. PSA values were obtained within 1 week of scan. Scans were interpreted by a local and central radiologist.
Results
22 men (aged 61 - 88) met inclusion criteria. 17 men had prior radical prostatectomy while 5 men had prior radiation therapy. PSA ranged from 0.3 to 37.4 ng/ml. Median PSA was 0.6 ng/ml. 100% of [F-18]SMS-5368 PET/CT scans yielded positive results. Patients were scanned up to 190 minutes with complete absence of tracer excretion into the urinary system. Sites of uptake included prostate bed/prostate (6, median PSA 1.2), pelvic lymph nodes (8, median PSA 0.4), bone (5, median PSA 0.5), soft tissue (1, median PSA 6.4) and lymph nodes/bone (2, median PSA 1.45). Spinal metastases were noted in 5 of 7 bony metastasis patients. 15 patients demonstrated locoregional recurrence while 7 patients exhibited distant metastasis. There was 100% agreement between local and central radiologist interpretation of PET/CT scans after consensus reading. There were no adverse events.
Conclusions
[F-18]SMS-5368 PET/CT detected prostate cancer recurrence at low PSA levels in men with BCR and negative conventional imaging. [F-18]SMS-5368 PET/CT scans were reproducibly interpreted by both local and central radiologists. The lack of [F-18]SMS-5368 tracer excretion into the urinary system may improve detection of local recurrence, better identifying candidates for salvage therapy. This preliminary data suggests high sensitivity for recurrent prostate cancer detection, however further clinical investigation is warranted.
Source Of Funding
Siemens Molecular Imaging funded this research
Sessions
MP18: Imaging/Uroradiology I
302B