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  • / Piflufolastat f 18-PET/CT in patients with prostate cancer: An analysis of  OSPREY (cohorts A and B) standardized uptake value (SUV) results stratified by PSA and Gleason score.

Piflufolastat F 18-PET/CT in patients with prostate cancer: An analysis of OSPREY (cohorts A and B) standardized uptake value (SUV) results stratified by PSA and Gleason score.

Abstract Poster

Authors

null

Michael A. Gorin

Johns Hopkins University School of Medicine, Baltimore, MD

Michael A. Gorin , Steven P. Rowe , Kenneth J. Pienta , Peter R. Carroll , Frederic Pouliot , Stephan Probst , Lawrence Saperstein , Mark Preston , Ajjai Shivaram Alva , Akash Patnaik , Nancy Stambler , Barry A. Siegel , Michael J. Morris

Organizations

Johns Hopkins University School of Medicine, Baltimore, MD, Department of Radiology, Johns Hopkins University School of Medicine, Baltimore, MD, James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD, Department of Urology, University of California San Francisco, San Francisco, CA, Cancer Research Center, Centre Hospitalier Universitaire (CHU) de Québec-Université Laval, Québec City, QC, Canada, Jewish General Hospital, Montréal, QC, Canada, Yale School of Medicine, New Haven, CT, Brigham and Women’s Hospital, Boston, MA, University of Michigan Rogel Comprehensive Cancer Center, Ann Arbor, MI, Department of Medicine, University of Chicago, Chicago, IL, Progenics Pharmaceuticals, Inc., New York, NY, Washington University School of Medicine in St. Louis, St. Louis, MO, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, New York, NY

Research Funding

Pharmaceutical/Biotech Company

Background: The OSPREY clinical trial was a phase 2/3 prospective study of prostate specific membrane antigen (PSMA) PET/CT using piflufolastat F 18. Piflufolastat F 18 (aka 18F-DCFPyL or PyL) is a novel PSMA-targeting radiopharmaceutical approved for imaging of PCa pts both at initial staging and for disease recurrence. Here we describe SUV results by biopsy status, baseline PSA levels, and Gleason score (GS). Methods: Piflufolastat F 18-PET/CT was evaluated in men with NCCN high-risk PCa scheduled to undergo radical prostatectomy with pelvic lymphadenectomy (RP-PLND) (Cohort A) and men with radiologically suspected recurrent/metastatic PCa (Cohort B). A single IV dose of 9 mCi (333 MBq) of piflufolastat F 18 was administered followed by PET/CT acquisition 1-2 hours later. Piflufolastat F 18 uptake in various lesion locations as defined by maximum and peak SUV (SUVmax, SUVpeak) were determined by three blinded, independent central readers for each tissue (e.g., bone, lymph nodes (LN), soft tissue). To measure SUVs, the reader placed a volume of interest (VOI) on each identified lesion. SUVmax was defined as the maximum single-voxel SUV within the VOI. SUVpeak within the VOI was defined as the average SUV within a fixed-sized VOI (1 cm diameter sphere), representing the cluster with the highest average SUV. Results: 345 men underwent piflufolastat F 18-PET/CT. Cohort B (n = 93evaluable) SUVmax and SUVpeak were significantly higher for biopsy positive (+)(one biopsy lesion/pt) when compared to biopsy negative (-) lesions from bone and LN. SUVpeak for biopsied bone and LN (Cohort B) appeared to increase with rising baseline PSA. In high-risk PCa pts, SUVpeak for prostate (Cohort A; n = 252 evaluable) increased with baseline PSA and were highest for GS 9-10 (Table). Conclusions: Piflufolastat F 18-PET/CT uptake was significantly higher in biopsy + lesions and increased with baseline PSA. Prostate SUVpeak was highest for GS 9-10. Clinical trial information: NCT02981368.


Lesion site
SUVmax*
SUVpeak*
Biopsy +
Biopsy -
P-value
Biopsy +
Biopsy -
P-value
median
n
median
n
median
n
median
n
Cohort B
Bone
15.4
38
2.5
15
0.0046
14
38
5
15
0.0031
LN
28.1
29
2.1
6
0.0012
19.3
29
1.8
6
0.0012
Soft tissue
30.1
6
2
1
0.2578
23.8
6
1.5
1
0.2578
SUVpeak
Lesion site
PSA (ng/mL)
0 to <0.2
0.2 to <4
4 to <20
20 to <50
≥50
median
n
median
n
median
n
median
n
median
n
Cohort B
Bone
1.3
4
5.43
17
11.3
20
9.7
6
9.4
6
LN
1.7
1
1.8
5
8.7
9
38.3
6
17
14
Soft tissue
0
0
55.33
2
59.2
1
0
0
10.3
4
Cohorts A&B
Aorta (SUVmean ref.)
1.7
5
1.4
43
1.4
218
1.4
46
1.4
32
Cohort A
Prostate
0
0
5.7
18
6.6
187
10.8
34
27.6
9
SUVpeak
Lesion site
GS
≤6
3+4
4+3
8
9-10
median
n
median
n
median
n
median
n
median
n
Cohort A
Prostate
5
2
5.5
48
7.8
81
6.1
25
8.2
88
Bone
0
0
0
0
2.4
10
2.5
3
1.8
10
LN
0
0
2.2
2
2.7
7
2.9
3
3.4
29
Soft tissue
0
0
5.6
2
7.1
4
0
0
8.5
11
Cohorts A&B
Aorta (SUVmean ref.)
1.2
2
1.4
48
1.5
83
1.4
26
1.5
88

*Cohorts A&B Aorta SUVmean ref.: 1.45 (n=320) & 1.43 (n=25) for Biopsy + & Biopsy -, respectively.

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary Cancer—Prostate, Testicular, and Penile

Track

Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track

Epidemiology/Outcomes

Clinical Trial Registration Number

NCT02981368

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 5024)

DOI

10.1200/JCO.2022.40.16_suppl.5024

Abstract #

5024

Poster Bd #

208

Abstract Disclosures

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