OncoMatch/Clinical Trials/NCT07831824
Dose Optimization and Diagnostic Performance in Prostate Cancer (SPARROW [Staging Prostate Cancer With Advanced RM2 Radiotracer Oncologic Workup])
Official title: A Prospective Phase 2/3, Multicenter, Open Label Study of [68Ga]- LNTH2401 PET/CT Imaging in Participants With Prostate Cancer: Phase 2 Dose Optimization in Either Newly Diagnosed or Biochemically Recurrent Prostate Cancer and Phase 3 Diagnostic Performance in Participants Who Are Newly Diagnosed and Have at Least High Risk or Suspected Metastatic Disease and Planning to Undergo Radical Prostatectomy Plus Pelvic Lymph Node Dissection (SPARROW)
Is NCT07831824 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2/3 trial studies [68Ga]-LNTH-2401 for prostate cancer.
Treatment: [68Ga]-LNTH-2401 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
Required: Stage HIGH-RISK (CLINICAL STAGE ≥T3A, OR PSA >20 NG/ML, OR GRADE GROUP 4-5 [GLEASON SCORE 8-10]), BIOCHEMICALLY RECURRENT
high-risk prostate cancer as defined by the National Comprehensive Cancer Network (NCCN) Guidelines, Version 5.2026 (clinical stage ≥T3a, or PSA >20 ng/mL, or Grade Group 4-5 [Gleason score 8-10]), and planned treatment with radical prostatectomy plus pelvic lymph node dissection (RP+PLND); Biochemically Recurrent Prostate Cancer (Phase 2 Only) Post-definitive-therapy disease with suspected recurrence, based on elevated prostate-specific antigen (PSA) following definitive therapy
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Lab requirements
Blood counts
WBC ≥ 2.5 × 10^9/L OR ANC ≥ 1.5 × 10^9/L; platelets ≥ 100 × 10^9/L
Kidney function
eGFR >60 mL/min/1.73 m2 (CKD EPI 2021, race-neutral); albumin ≥ 30 g/L
Liver function
Total bilirubin ≤ 1.5 × institutional ULN (≤ 3 × ULN if Gilbert's syndrome); ALT and AST ≤ 3.0 × ULN
Adequate organ function, defined as follows: Bone marrow reserve: WBC ≥ 2.5 × 10^9/L OR ANC ≥ 1.5 × 10^9/L; platelets ≥ 100 × 10^9/L. Liver function: Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN if Gilbert's syndrome); ALT and AST ≤ 3.0 × ULN. Renal function: eGFR >60 mL/min/1.73 m2 (CKD EPI 2021, race-neutral); albumin ≥ 30 g/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- BAMF Health · Grand Rapids, Michigan
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07831824 currently recruiting?
Yes, this trial is currently recruiting patients.
What disease stage is eligible?
Stage HIGH-RISK (CLINICAL STAGE ≥T3A, OR PSA >20 NG/ML, OR GRADE GROUP 4-5 [GLEASON SCORE 8-10]) or BIOCHEMICALLY RECURRENT is required.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages