This is an open-label, nonrandomized, multicenter study conducted in two sequential parts: an initial Phase 2 Dose Optimization Period followed by the Phase 3 Diagnostic Performance Period.
After the optimal administered activity and imaging time window are selected in Phase 2, Phase 3 will enroll participants with recently diagnosed PCa who are at least high risk or have suspected metastatic disease and are eligible for radical prostatectomy with pelvic lymph node dissection (RP+PLND).
Safety assessments throughout the study will include monitoring of adverse events, vital signs, ECGs, and clinical laboratory parameters.
Participants will be enrolled sequentially in a nonrandomized manner, with competitive enrollment across study sites.
Participants must be male and ≥18 years old or defined as adults per applicable local laws and regulations, at the time of signing the informed consent.
Use 2 highly effective contraceptive methods when engaging in sexual intercourse with partners who are pregnant or of childbearing potential (Appendix 2).
Refrain from donating sperm.
Participants who are claustrophobic must be willing to take an anti-anxiety medication prescribed by their physician one hour prior to the scan.
Participants that have been administered any high-energy (> 300 KeV) gamma-emitting radioisotope within 5 physical half-lives, or any intravenous (IV) iodinated contrast medium within 24 hours, or any high-density oral contrast medium (oral water contrast is acceptable) within 5 days prior to study drug injection.
Participants are excluded if they have received any other prior anti-cancer therapy (including radioligand therapy) or investigational agent within ≤28 days (or 5 half-lives, whichever is shorter) prior to the first dose of study treatment. Note: Prior external beam radiation therapy (EBRT) is permitted for Phase 2 participants with BCR PCa only.
Participants who are planning to undergo alternate medical procedures for prostate cancer from the time of dosing (Day 1) to surgery.
History of malignancy other than prostate cancer that, in the opinion of the Investigator, is expected to alter life expectancy or may interfere with study assessments, including imaging interpretation or histopathological evaluation. Participants with adequately treated nonmelanoma skin cancer, superficial bladder cancer, or other malignancies that have been disease free for more than 2 years are eligible.
Single group
[68Ga]-LNTH-2401
Drug\[68Ga\]-LNTH-2401 will be administered to identify newly diagnosed prostate cancer.
Phase 2 Dose Optimization Period: Optimal administered activity (radioactivity) and imaging time window for [68Ga]-LNTH-2401 PET/CT based on image quality and interpretability in participants with either newly diagnosed or BCR PCa
Image quality scores (IQS) for administered activity (radioactivity) for \[68Ga\]-LNTH-2401 PET/CT
Phase 2 Dose Optimization Period : Optimal administered activity (radioactivity) and imaging time window for [68Ga]-LNTH-2401 PET/CT based on image quality and interpretability in participants with either newly diagnosed or BCR PCa
Image quality scores (IQS) for imaging time windows for \[68Ga\]-LNTH-2401 PET/CT
Phase 2 Dose Optimization Period :Biodistribution and radiation dosimetry of [68Ga]-LNTH-2401 in participants with either newly diagnosed or BCR PCa.
Time activity curves (TACs), describing the percentage of the injected activity versus time will be derived for standard organs. Absorbed radiation doses of \[68Ga\]-LNTH-2401in standard organs; whole-body effective dose will also be estimated.
Safety and tolerability of [68Ga] LNTH 2401 in participants with either newly diagnosed or BCR PCa.
Frequency and severity of AEs per CTCAE version 6.0 for \[68Ga\]-LNTH-2401.
Phase 2 Dose Optimization Period- Refine the GRPR positivity definition
Prior and newly collected radioactivity uptake data (e.g., SUVmean, SUVmax ranges)
Phase 3 Diagnostic Performance Period- Evaluation of the safety and tolerability of [68Ga]-LNTH-2401.
Frequency and severity of AEs per CTCAE version 6.0 for \[68Ga\]-LNTH-2401. Changes in clinical laboratory parameters (e.g., hematology, chemistry), vital signs, and ECG parameters after administration of \[68Ga\]-LNTH 2401.
Phase 3 Diagnostic Performance Period- Determination of (true) detection rates of [68Ga]-LNTH-2401 and conventional imaging (CT/MRI of pelvis, ultrasound, bone scan) or PSMA PET/CT or PET/MRI among anatomic regions
The true detection and detection rates of \[68Ga\]-LNTH-2401 PET/CT among regions (e.g., bone, pelvic lymph nodes, extra-pelvic lymph nodes, soft tissue, prostate gland) between \[68Ga\]-LNTH-2401 and conventional (CT/ MRI of pelvis, ultrasound, bone scan) and/or PSMA PET imaging. Comparison of detection rates between PSMA and GRPR imaging, based on pre-specified analysis.
Phase 3 Diagnostic Performance Period- Assessment of the diagnostic performance of [68Ga]-LNTH-2401 PET/CT imaging of prostate cancer within the prostatic region.
Specificity (TN/ \[TN + FP\]) of \[68Ga\] LNTH-2401 PET/CT imaging to determine the absence of prostate cancer within prostatic region relative to histopathology. Sensitivity (TP/ \[TP + FN)\] of \[68Ga\]-LNTH-2401 PET/CT imaging a to determine the presence of prostate cancer within prostate relative to histopathology.
Click on the lead sponsor to view all of their trials.
