PET Scan Agent for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AdventHealth
Must not be taking: Androgen deprivation therapy
Disqualifiers: X-ray contrast, Other PET radiotracer, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer.
The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently receiving Androgen Deprivation Therapy (ADT).
What data supports the effectiveness of the drug 18F-rhPSMA-7.3 (Posluma) for prostate cancer?
The drug 18F-rhPSMA-7.3 (Posluma) has shown high effectiveness in detecting prostate cancer recurrence, with a detection rate of up to 95.7% in patients with higher PSA levels. It also led to changes in treatment plans for nearly two-thirds of patients, indicating its potential impact on managing prostate cancer.
12345Is the PET scan agent 18F-rhPSMA-7.3 (Posluma) safe for use in humans?
The PET scan agent 18F-rhPSMA-7.3 (Posluma) has been approved in the USA for imaging prostate cancer, indicating it has undergone safety evaluations. Studies show it has similar radiation doses to healthy organs compared to other agents, with promising results for tumor targeting, suggesting it is generally safe for human use.
13467How is the drug 18F-rhPSMA-7.3 (Posluma) different from other prostate cancer treatments?
18F-rhPSMA-7.3 (Posluma) is unique because it is a radioactive imaging agent specifically designed for PET scans to detect prostate-specific membrane antigen (PSMA) in prostate cancer, helping to identify cancer spread more accurately than conventional imaging methods. This can lead to significant changes in treatment plans for patients with suspected cancer recurrence.
12345Eligibility Criteria
This trial is for men who have had surgery to remove prostate cancer and now have low but rising PSA levels, suggesting the cancer might be coming back. Participants should not have received any other post-surgery cancer treatments.Inclusion Criteria
An elevated PSA test result that is greater than or equal to 0.1 ng/ml and less than 0.5
I had surgery to remove prostate cancer aimed at curing it.
Exclusion Criteria
I am scheduled for an x-ray or PET scan with a contrast agent within 24 hours before my PSMA-PET scan.
I am currently on hormone therapy for prostate cancer.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
PET Scan
Participants receive a PET scan with 18F-rhPSMA-7.3 to detect prostate cancer
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the PET scan
24 months
Safety follow-up call within 24 hours of each injection/scan
Participant Groups
The study is testing Posluma (18F-rhPSMA-7.3), a radioactive agent used in PET scans, to see if it can detect returning prostate cancer at very low PSA levels after previous surgery.
1Treatment groups
Experimental Treatment
Group I: Open Label Main ArmExperimental Treatment1 Intervention
Single Arm receiving PET scan with 18F-rhPSMA-7.3 (Posluma)
18F-rhPSMA-7.3 (Posluma) is already approved in United States for the following indications:
🇺🇸 Approved in United States as Posluma for:
- Positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
AdventHealthOrlando, FL
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Who Is Running the Clinical Trial?
AdventHealthLead Sponsor
Blue Earth DiagnosticsIndustry Sponsor
References
Flotufolastat F 18: Diagnostic First Approval. [2023]Flotufolastat F 18 (POSLUMA®) is an 18F-labelled radiohybrid (rh) prostate-specific membrane antigen (PSMA)-targeted imaging agent being developed by Blue Earth Diagnostics, a subsidiary of Bracco Imaging, for prostate cancer imaging. In May 2023, flotufolastat F 18 received its first approval in the USA as a radioactive diagnostic agent for positron emission tomography (PET) of PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. This article summarizes the milestones in the development of flotufolastat F 18 leading to this first approval.
Piflufolastat F-18 (18F-DCFPyL) for PSMA PET imaging in prostate cancer . [2022]Label="INTRODUCTION">Accurate imaging is essential for staging prostate cancer and guiding management decisions. Conventional imaging modalities are hampered by a limited sensitivity for metastatic disease. Nearly all prostate cancers express prostate-specific membrane antigen (PSMA) and 18F-DCFPyL (piflufolastat F 18) is a new FDA-approved positron emission tomography (PET) agent that targets PSMA for improved staging of prostate cancer.
Impact of piflufolastat F-18 PSMA PET imaging on clinical decision-making in prostate cancer across disease states: A retrospective review. [2023]Piflufolastat F-18 (18F-DCFPyL) prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging is approved by the US food and drug administration for initial staging of high-risk prostate cancer, biochemical recurrence (BCR), and restaging of metastatic prostate cancer. Here, we sought to assess how its integration into clinical care may have impacted the management of patients.
Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. [2023]Prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) is rapidly becoming widely accepted as the standard-of-care for imaging of men with prostate cancer. Labeled indications for regulatoryapproved agents include primary staging and recurrent disease in men at risk of metastases. The first commercial PSMA PET agent to become available was 18F-DCFPyL (piflufolastat F 18), a radiofluorinated small molecule with high-affinity for PSMA. The regulatory approval of 18F-DCFPyL hinged upon two key, multi-center, registration trials, OSPREY (patient population: highrisk primary staging) and CONDOR (patient population: biochemical recurrence). In this manuscript, we will (1) review key findings from the OSPREY and CONDOR trials, (2) discuss the clinical acquisition protocol we use for 18F-DCFPyL PET scanning, (3) present information on important pearls and pitfalls, (4) provide an overview of the PSMA reporting and data system (PSMA-RADS) interpretive framework, and (5) posit important future directions for research in PSMA PET. Our overall goal is to provide a brief introduction for practices and academic groups that are adopting 18F-DCFPyL PET scans for use in their patients with prostate cancer.
Detection efficacy of 18F-rhPSMA-7.3 PET/CT and impact on patient management in patients with biochemical recurrence of prostate cancer after radical prostatectomy and prior to potential salvage treatment. [2022]Purpose: Radiohybrid prostate-specific membrane antigen (rhPSMA) ligands are a new class of 18F-labeled PSMA-targeting agents. 18F-rhPSMA-7.3 is a lead compound which is currently under investigation in two multicenter phase III trials for PET-imaging. Here, we report the first retrospective data on its detection efficacy and potential impact on clinical management in a homogeneous cohort of patients with biochemical recurrence after radical prostatectomy, and prior to any salvage therapy. Methods: 242 patients (median [range] PSA, 0.60 [0.2-60.8] ng/mL) who underwent 18F-rhPSMA-7.3 PET/CT were retrospectively selected from the institutions' database. Images were re-read by an experienced nuclear medicine physician. Lesion detection rates were stratified by PSA. Further, potential management before and after PET was assessed by an interdisciplinary simulated tumor board and categorized (major vs. minor vs. no therapeutic change). The distribution of management change identified in each PSA subgroup was determined. Results: In total, 176/242 (72.7%) patients showed PSMA-ligand positive findings. 18F-rhPSMA-7.3 detection rates were 61.8% (63/102), 67.9% (38/56), 81.1% (30/37) and 95.7% (45/47) for PSA-levels of 0.2-<0.5 ng/mL, 0.5-<1 ng/mL, 1-<2 ng/mL and ≥2 ng/mL, respectively. 18F-rhPSMA-7.3 PET/CT revealed local recurrence, pelvic lymph node metastases, retroperitoneal lymph nodes metastases, supradiaphragmatic lymph nodes, bone metastases, and visceral metastases in 48.8% (n = 118), 28.9% (n = 70), 6.6% (n = 16), 1.2% (n = 3), 13.2% (n = 32) and 1.2% (n = 3) of patients, respectively. Notably, bone lesions were identified in 8.8% of patients (9/102) with PSA <0.5 ng/mL. Results from the interdisciplinary simulated tumor board indicated change of therapeutic management in 153/242 patients (63.2%) with 54/242 (22.3%) considered major and 99/242 (40.9%) minor, respectively. 18F-rhPSMA-7.3 PET/CT did not prompt any therapeutic changes in 64/242 patients (26.4%). Conclusion: 18F-rhPSMA-7.3 PET offers high detection efficacy in patients with biochemical recurrence after radical prostatectomy, and prior to potential salvage therapy, and results in a potential change in treatment plans in nearly 2/3 of patients. Keywords: Biochemical recurrence; hybrid imaging; positron emission tomography; prostate cancer; prostate-specific membrane antigen.
Pretherapeutic Comparative Dosimetry of 177Lu-rhPSMA-7.3 and 177Lu-PSMA I&T in Patients with Metastatic Castration-Resistant Prostate Cancer. [2023]Radiohybrid prostate-specific membrane antigen (rhPSMA) ligands allow for labeling with 18F and radiometals for endoradiotherapy. rhPSMA-7.3 has been designated as a lead compound with promising preclinical data for 177Lu-rhPSMA-7.3, which has shown higher tumor uptake than 177Lu-PSMA I&T. In this retrospective analysis, we compared pretherapeutic clinical dosimetry data of both PSMA ligands. Methods: Six patients with metastatic castration-resistant prostate cancer underwent both 177Lu-rhPSMA-7.3 and 177Lu-PSMA I&T pretherapeutic dosimetry. Whole-body scintigraphy was performed at 1 h, 4 h, 24 h, 48 h, and 7 d after injection. Regions of interest covering the whole body, organs, bone marrow, and tumor lesions were drawn for each patient. Absorbed doses for individual patients and pretherapeutic applications were calculated using OLINDA/EXM. To facilitate the comparison of both ligands, we introduced the therapeutic index (TI), defined as the ratio of mean pretherapeutic doses to tumor lesions over relevant organs at risk. Results: Mean whole-body pretherapeutic effective doses for 177Lu-rhPSMA-7.3 and 177Lu-PSMA I&T were 0.12 ± 0.07 and 0.05 ± 0.03 Sv/GBq, respectively. Mean absorbed organ doses for 177Lu-rhPSMA-7.3 and 177Lu-PSMA I&T were, for example, 1.65 ± 0.28 and 0.73 ± 0.18 Gy/GBq for the kidneys, 0.19 ± 0.09 and 0.07 ± 0.03 Gy/GBq for the liver, 2.35 ± 0.78 and 0.80 ± 0.41 Gy/GBq for the parotid gland, and 0.67 ± 0.62 and 0.30 ± 0.27 Gy/GBq for the bone marrow, respectively. Tumor lesions received mean absorbed doses of 177Lu-rhPSMA-7.3 and 177Lu-PSMA I&T of 6.44 ± 6.44 and 2.64 ± 2.24 Gy/GBq, respectively. The mean TIs for the kidneys were 3.7 ± 2.2 and 3.6 ± 2.2 for 177Lu-rhPSMA-7.3 and 177Lu-PSMA I&T, respectively, and those for the bone marrow were 15.2 ± 10.2 and 15.1 ± 10.2 for 177Lu-rhPSMA-7.3 and 177Lu-PSMA I&T, respectively. Conclusion: Pretherapeutic clinical dosimetry confirmed preclinical results of mean absorbed doses for tumors that were 2-3 times higher for 177Lu-rhPSMA-7.3 than for 177Lu-PSMA I&T. Absorbed doses to normal organs also tended to be higher for 177Lu-rhPSMA-7.3, resulting overall in similar average TIs for both radiopharmaceuticals with considerable interpatient variability. 177Lu-rhPSMA-7.3 has promise for a therapeutic efficacy similar to that of 177Lu-PSMA I&T at smaller amounts of injected activity, simplifying radiation safety measurements (especially for large patient numbers or dose escalation regimens).
Comparative Preclinical Biodistribution, Dosimetry, and Endoradiotherapy in Metastatic Castration-Resistant Prostate Cancer Using 19F/177Lu-rhPSMA-7.3 and 177Lu-PSMA I&T. [2022]Radiohybrid prostate-specific membrane antigen (rhPSMA) ligands are applicable as radiochemical twins for both diagnostic PET imaging and endoradiotherapy. On the basis of preliminary data as a diagnostic ligand, the isomer rhPSMA-7.3 is a promising candidate for potential endoradiotherapy. The aim of this preclinical evaluation was to assess the biodistribution, dosimetry, and therapeutic efficacy of 19F/177Lu-rhPSMA-7.3 in comparison to the established therapeutic agent 177Lu-PSMA I&T (imaging and therapy). Methods: The biodistribution of 19F/177Lu-rhPSMA-7.3 and 177Lu-PSMA I&T was determined in LNCaP tumor-bearing severe combined immunodeficiency (SCID) mice after sacrifice at defined time points up to 7 d (n = 5). Organs and tumors were dissected, percentage injected dose per gram (%ID/g) was determined, and dosimetry was calculated using OLINDA/EXM, version 1.0. The therapeutic efficacy of a single 30-MBq dose of 19F/177Lu-rhPSMA-7.3 (n = 7) was compared with that of 177Lu-PSMA I&T in treatment groups (n = 7) and control groups (n = 6-7) using C4-2 tumor-bearing SCID mice by evaluating tumor growth and survival over 6 wk after treatment. Results: The biodistribution of 19F/177Lu-rhPSMA-7.3 revealed fast blood clearance (0.63 %ID/g at 1 h after injection), and the highest activity uptake was in the spleen and kidneys, particularly in the first hour (33.25 %ID/g and 207.6 %ID/g, respectively, at 1 h after injection), indicating a renal excretion pathway. Compared with 177Lu-PSMA I&T, 19F/177Lu-rhPSMA-7.3 exhibited an initial (1 h) 2.6-fold higher tumor uptake in LNCaP xenografts and a longer retention (4.5 %ID/g vs. 0.9 %ID/g at 168 h). The tumor dose of 19F/177Lu-rhPSMA-7.3 was substantially higher (e.g., 7.47 vs. 1.96 µGy/MBq at 200 mm3) than that of 177Lu-PSMA I&T. In most organs, absorbed doses were higher for 177Lu-PSMA I&T. A significantly greater tumor size reduction was shown for a single dose of 19F/177Lu-rhPSMA-7.3 than for 177Lu-PSMA I&T at the end of the experiment (P = 0.0167). At the predefined termination of the experiment at 6 wk, 7 of 7 and 3 of 7 mice were still alive in the 19F/177Lu-rhPSMA-7.3 and 177Lu-PSMA I&T groups, respectively, compared with the respective control groups, with 0 of 7 and 0 of 6 mice. Conclusion: Compared with 177Lu-PSMA I&T, 19F/177Lu-rhPSMA-7.3 can be considered a suitable candidate for clinical translation because it has similar clearance kinetics and a similar radiation dose to healthy organs but superior tumor uptake and retention. Preliminary treatment experiments showed a favorable antitumor response.