Dose Optimization and Diagnostic Performance in Prostate Cancer (SPARROW [Staging Prostate Cancer With Advanced RM2 Radiotracer Oncologic Workup])
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Heart tracing (ECG), CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Safety assessments throughout the study will include monitoring of adverse events, vital signs, ECGs, and clinical laboratory parameters."
- "Up to 12 participants with GRPR-positive lesion(s) will undergo serial PET/CT scans at multiple time points during the first imaging visit to assess dosimetry and biodistribution."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the dose, scan timing, and ability of a radioactive imaging drug to find prostate cancer. It is for adult men with newly diagnosed, high-risk prostate cancer who plan to have surgery. The first part also includes men whose prostate cancer may have returned after treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be male and at least 18 years old, or meet the local legal age for adults.
- Have prostate cancer confirmed by a tissue or cell test.
- Have newly diagnosed, high-risk cancer and plan surgery to remove the prostate and nearby pelvic lymph nodes. In Phase 2 only, men may instead have cancer suspected to have returned after treatment, based on required PSA blood test levels.
- Be able to care for yourself and be up and moving for at least half of your waking hours.
- Have blood counts, liver tests, kidney tests, and blood protein levels that meet study limits.
- If sexually active, agree to use two highly effective birth control methods with partners who are pregnant or could become pregnant. Do not donate sperm during the study or for 7 days after the last dose.
- If afraid of tight spaces, be willing to take prescribed medicine for anxiety one hour before the scan.
- Be able and willing to follow the study schedule, treatments, and tests.
Who can't join
- Have had certain radioactive substances or scan dyes too close to the study injection. Limits include 24 hours for iodine dye given into a vein and 5 days for dense dye taken by mouth.
- Have had cancer treatment or an experimental drug within 28 days, or a shorter time based on how long the drug stays in the body. Prior external radiation is allowed only for Phase 2 participants whose cancer may have returned.
- Plan other prostate cancer procedures between the study dose and surgery, or have scans showing cancer spread that rules out surgery.
- Have another cancer that could affect life expectancy or study results. Some treated skin or bladder cancers, and other cancers gone for more than 2 years, are allowed.
- Have a condition or life situation that could prevent safe, reliable participation, or be taking part in another clinical study at screening.
- Have a known allergy or other medical reason not to receive the study drug, [68Ga]-LNTH-2401, or its ingredients.
- Have current or past cancer spread to the brain or spinal cord, or serious heart disease or heart rhythm risks.
- Still have side effects from cancer treatment that are more than mild.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: Participants must meet all of the criteria below as defined to be enrolled in the study. 1. 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. 2. Participants who are sexually active must agree to the following during the study and for 7 days after last administration of study drug: 1. Use 2 highly effective contraceptive methods when engaging in sexual intercourse with partners who are pregnant or of childbearing potential (Appendix 2). 2. Refrain from donating sperm. 3. Participants who are claustrophobic must be willing to take an anti-anxiety medication prescribed by their physician one hour prior to the scan. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Adequate organ function, 5. Adequate organ function, defined as follows: Bone marrow reserve: * White blood cell count ≥ 2.5 × 109/L OR absolute neutrophil count (ANC) ≥ 1.5 × 109/L * Platelets ≥ 100 × 109/L * Platelets ≥ 100 × 109/L Liver function: * Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN). For participants with known Gilbert's syndrome, ≤ 3 × ULN is permitted. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN Renal function: * Estimated glomerular filtration rate (eGFR \>60 mL/min/1.73 m2) calculated using the CKD EPI 2021 creatinine equation (race-neutral).80 The eGFR must be derived from a serum creatinine value measured at Screening * Albumin ≥ 30 g/L. 6. All participants must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate and meet either disease population based on the phase specific criteria below, as applicable. 1. Newly Diagnosed Prostate Cancer (Phase 2 and 3): 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) or 2. Biochemically Recurrent Prostate Cancer (Phase 2 Only) Post-definitive-therapy disease with suspected recurrence, based on elevated prostate-specific antigen (PSA) following definitive therapy, meeting one of the following criteria: * Post-radical prostatectomy (RP): Detectable or rising serum PSA ≥0.2 ng/mL with a confirmatory serum PSA ≥0.2 ng/mL, consistent with American Urological Association (AUA) recommendations; or * Post-radiation therapy (RT), cryotherapy, or brachytherapy: Increase in serum PSA ≥2.0 ng/mL above the nadir, consistent with the American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition. 7. Must be able and willing to comply with all study requirements and treatments as well as the timing and nature of required assessments. Exclusion Criteria: Participants meeting any of the following exclusion criteria are not eligible for this study. 1. 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. 2. 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. 3. Participants who are planning to undergo alternate medical procedures for prostate cancer from the time of dosing (Day 1) to surgery. 4. 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. 5. Any medical, psychological, familial, sociological, or geographical condition that, in the opinion of the Investigator, may compromise the participant's ability to comply with study requirements, undergo study procedures, or result in the collection of reliable data. 6. Active participation in another clinical study at the time of screening for this study. 7. Known contraindications or hypersensitivity to \[68Ga\]-LNTH-2401 and/or excipients. 8. Clinical evidence or history of central nervous system metastases. 9. Clinically significant cardiovascular disease, that in the opinion of the Investigator may pose an unacceptable risk to the participant or interfere with study assessments. This includes any of the following: 1. recent myocardial infarction or arterial thrombotic events (in the past 6 months); current history of New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, or severe uncontrolled ventricular arrhythmias; or bradycardia or left ventricular ejection fraction measurement of 2. history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, congenital long QT syndrome, and/or familial history of prolonged QT syndrome) or taking medication known to cause QT/QTc prolongation; or marked baseline prolongation of the QT/QTc interval (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, \>450 ms). 10. Treatment-related adverse events from prior or concurrent therapies that have not resolved to grade ≤1 according to the CTCAE Version 6.0. 11. Imaging evidence of metastatic disease that precludes surgical indication.
Study sites (1)
MI
- BAMF Health · Grand Rapids, MI 49503Harshad Kulkarni, MD · Study contact · harshad.kulkarni@bamfhealth.comMore trials in Grand Rapids