Posluma (flotufolastat)
Research Synopsis
- Recent studies on Posluma (flotufolastat) indicate that it is a newly approved imaging agent specifically targeting prostate cancer, particularly utilized in PET scans.
- Its first FDA approval was granted in May 2023, enabling its use in detecting metastatic or recurring prostate cancer lesions.
- Research shows that the qualitative and quantitative assessment of urinary activity in PET scans with flotufolastat displayed minimal impact on interpretation in 96% of cases, affirming its reliability.
- The SPOTLIGHT study highlighted a notable 95% detection rate for true-positive lesions in patients with biochemical recurrence and negative conventional imaging.
- Exploratory analysis from the SPOTLIGHT study revealed that increased baseline PSA levels correlated with higher detection rates, demonstrating the drug's effectiveness across various clinical scenarios.
- Additionally, the reproducibility of PET/CT scan interpretations with flotufolastat showed strong interreader and intrareader agreement, supporting its consistent application in clinical settings.
- The SPOTLIGHT study also underscored its effectiveness in African American patients, where a 93% detection rate was observed, helping to improve representation in clinical trials.
- Ongoing research into educational training for interpreting PSMA PET imaging is vital, as discrepancies in training could lead to inconsistent clinical reporting.
- Overall, Posluma marks a significant advancement in the diagnostic capabilities for prostate cancer, reflecting promising results from recent clinical studies.
- Continued research and education on its application will be essential for maximizing its potential benefits in patient management.
Posluma (flotufolastat)
Flotufolastat F 18: Diagnostic First Approval.
London, UK
2 hours ago
1 Received
- Flotufolastat F 18 (POSLUMA) is a new imaging agent targeted at prostate-specific membrane antigen (PSMA) being developed for prostate cancer by Blue Earth Diagnostics.
- In May 2023, it received its first approval in the USA for use in positron emission tomography (PET) scans of prostate cancer lesions in men suspected of metastasis or recurrence.
- The article discusses the key developments and milestones that led to the approval of flotufolastat F 18 for clinical use.
$100 - $150
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2023 FDA TIDES (Peptides and Oligonucleotides) Harvest.
London, UK
2 hours ago
1 Received
- In 2023, the FDA approved nine TIDES, including four oligonucleotides targeting disorders like ALS, geographic atrophy, primary hyperoxaluria type 1, and hereditary transthyretin-mediated amyloidosis, all with enhanced stability and effectiveness.
- The approved peptides exhibit a variety of structures (linear, cyclic, and lipopeptides) and applications, including the first orphan drug designation for a peptide-based chemokine antagonist.
- Notably, a peptide-based treatment was approved for core symptoms of Rett syndrome, with the analysis of TIDES focusing on their chemical structure, medical targets, and potential side effects.
$100 - $150
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Quantitative and Qualitative Assessment of Urinary Activity of F-Flotufolastat-PET/CT in Patients with Prostate Cancer: a Post Hoc Analysis of the LIGHTHOUSE and SPOTLIGHT Studies.
London, UK
2 hours ago
1 Received
- A study was conducted to determine how urinary activity affects the interpretation of F-flotufolastat (F-rhPSMA-7.3) PET/CT scans in prostate cancer patients from two clinical trials, LIGHTHOUSE and SPOTLIGHT.
- The analysis involved 718 scans evaluated by three certified nuclear medicine physicians, focusing on both qualitative and quantitative assessments of bladder activity and its impact on imaging results.
- Results showed that 96% of the scans were interpreted as having no or minimal impact from urinary activity, while only a small portion (3.4%) indicated that urinary activity significantly interfered with the assessment, particularly when bladder activity was higher.
$100 - $150
Hourly Rate
PSMA-targeted radiotheranostics in modern nuclear medicine: then, now, and what of the future?
London, UK
2 hours ago
1 Received
- * The complexities of prostate cancer present challenges for imaging, monitoring, and treatment, leading to the development of theranostics, which combines targeted imaging and therapy.
- * Prominent advancements in radiotheranostics include FDA-approved PSMA-targeted imaging and therapy agents, representing significant progress in managing prostate cancer, alongside ongoing research into ligand-drug and immune therapies.
$100 - $150
Hourly Rate
True-Positive F-Flotufolastat Lesions in Patients with Prostate Cancer Recurrence with Baseline-Negative Conventional Imaging: Results from the Prospective, Phase 3, Multicenter SPOTLIGHT Study.
London, UK
2 hours ago
1 Received
- F-rhPSMA-7.3 (F-flotufolastat) is a diagnostic radiopharmaceutical used for PET imaging to identify prostate cancer lesions in patients with biochemical recurrence and negative conventional imaging.
- The SPOTLIGHT study evaluated the effectiveness of F-flotufolastat PET/CT by comparing results against histopathology and follow-up imaging to confirm findings.
- Results showed a detection rate of 95% and a verified detection rate of 64%, with notable true-positive lesions found in both the prostate bed and pelvic lymph nodes among the evaluated patients.
$100 - $150
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Impact of Clinical Factors on F-Flotufolastat Detection Rates in Men With Recurrent Prostate Cancer: Exploratory Analysis of the Phase 3 SPOTLIGHT Study.
London, UK
2 hours ago
1 Received
- F-Flotufolastat is a newly approved diagnostic imaging drug targeting prostate cancer, evaluated in the SPOTLIGHT clinical trial, which aimed to understand its detection rates based on clinical factors in men suspected of prostate cancer recurrence.* -
- The study involved 389 men and found that detection rates increased significantly with higher baseline prostate-specific antigen (PSA) levels, identifying lesions in 39% of those with prior radical prostatectomy and 43% of those with prior radiation therapy.* -
- Despite varying PSA doubling times and pathologic grades, the detection rates remained consistently high across different patient categories, suggesting effectiveness of F-flotufolastat across a wide range of clinical scenarios.*
$100 - $150
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Interreader and Intrareader Reproducibility of F-Flotufolastat Image Interpretation in Patients with Newly Diagnosed or Recurrent Prostate Cancer: Data from Two Phase 3 Prospective Multicenter Studies.
London, UK
2 hours ago
1 Received
- A study evaluated the reproducibility of F-flotufolastat PET/CT scans in both newly diagnosed and recurrent prostate cancer patients using masked image readings from three independent readers.
- The results showed high interreader agreement, with over 95% for newly diagnosed patients and at least 75% for recurrent cases, despite some complexities in the statistical analysis.
- Intrareader reliability, when readers re-evaluated a subset of images, was also strong, maintaining over 86% agreement across both patient groups, indicating that these scans can be interpreted consistently.
$100 - $150
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PPV of Bone Uptake of F-Flotufolastat: Evaluation Using SPOTLIGHT Study Data.
London, UK
2 hours ago
1 Received
$100 - $150
Hourly Rate
F-Flotufolastat Positron Emission Tomography in African American Patients With Suspected Prostate Cancer Recurrence: Findings From the Phase 3 SPOTLIGHT Study.
London, UK
2 hours ago
1 Received
- - The SPOTLIGHT study aimed to improve representation of African American (AA) patients in prostate cancer clinical trials, finding that 17% of enrolled patients were AA, which is above the typical rate of 8.5% in oncology trials.
- - Using a novel diagnostic tool, F-flotufolastat, the study evaluated its effectiveness in detecting prostate cancer in AA patients, recording a 93% detection rate which varied with prostate-specific antigen levels.
- - Although the overall detection rate for AA patients was slightly higher in those with intact prostates, both AA and non-AA patients had similar performance after prostate surgery, with verified detection rates at 64% and positive predictive values at 68% for AA patients
$100 - $150
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Evaluation of online teaching modules for PSMA PET interpretation.
London, UK
2 hours ago
1 Received
- * An analysis of the training resources from different companies and organizations revealed that their educational materials vary widely in length (20 to 315 minutes) and content, specifically the number of interpretive tips and pitfalls offered (approximately 12-30).
- * These differences in training modules highlight the potential for variability in interpretation among healthcare providers, depending on which training they have undergone and the specific radiotracers they utilize.
$100 - $150
Hourly Rate
Combining PSMA-PET and PROMISE to re-define disease stage and risk in patients with prostate cancer: a multicentre retrospective study.
London, UK
2 hours ago
1 Received
- PSMA-PET, introduced in 2012, has significantly improved prostate cancer staging, leading to the development of the PROMISE criteria for standardized imaging reports.
- This study analyzed data from a large cohort of prostate cancer patients across multiple German hospitals to assess the prognostic value of PROMISE staging in comparison to existing clinical risk assessment models.
- The findings from 2,414 patients revealed that PPP staging had performance metrics comparable to established clinical risk scores, thus highlighting its potential usefulness in predicting overall survival outcomes.
$100 - $150
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Matched-pair analysis of mCRPC patients receiving Lu-labeled PSMA-targeted radioligand therapy in a 4-week versus 6-week treatment interval.
London, UK
2 hours ago
1 Received
- A study was conducted to evaluate the effects of 4-week vs. 6-week treatment intervals for Lu-labeled prostate-specific membrane antigen-targeted radioligand therapy in patients with metastatic castration-resistant prostate cancer (mCRPC).
- The results showed that the 4-week interval led to a higher PSA response (47.8% vs. 21.7%) and longer PSA-progression-free survival (26.0 weeks vs. 18.0 weeks), but the overall survival rates were not significantly different (15.1 months vs. 18.4 months).
- The 4-week treatment increased the risk of blood count reductions compared to the 6-week interval, suggesting a need for more research to
$100 - $150
Hourly Rate