A Phase 2/3 interventional study of [68Ga]-LNTH-2401 in Prostate Cancer, sponsored by Lantheus Medical Imaging. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Lantheus Medical Imaging (part of Lantheus Holdings, Inc.) · Phase 2/3, Interventional, and Diagnostic
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Among 11 studies testing Gallium-68 in Prostatic Neoplasms — 8 open to participants now, 8 under way, 2 of them phase 3. Gallium-68 · Prostatic Neoplasms.
Among the 11 studies testing Gallium-68 in Prostatic Neoplasms, this one has the largest planned enrollment, is one of 6 that started in 2026, is one of 2 in phase 2/3, and was the 10th registered.
7,047 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →8 of the 11 studies testing Gallium-68 in Prostatic Neoplasms are open now, in 3 countries. Recruiting first, the newest first:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Sites in China
Ages 18–80 · Men only
Integrated Haematology and Oncology Network · Sites in Australia
Ages 18+
RenJi Hospital · Sites in China
Ages 18–75
Anhui Provincial Hospital · Sites in China
Ages 18–90 · Men only · Healthy volunteers
Anhui Provincial Hospital · Sites in China
Ages 18–90 · Men only · Healthy volunteers
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 5 · Phase 3 2
First in 2018; this study’s year is marked. 6 started in 2026.
This study's planned enrollment of 408 is above the median of 60 across 5,349 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 40 across the 11 interventional studies. Of the 3 that completed or were terminated, 1 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 11 have an industry lead sponsor. The 9 most frequent:
This study is registered under Lantheus Medical Imaging, one of the names counted as Lantheus Holdings, Inc.. Under that name alone:
Lantheus Medical Imaging is the lead sponsor of 30 studies on the registry; 3 are open to participants now.
22 studies in Prostatic Neoplasms by Lantheus Holdings, Inc.: 1 open now, 3 under way, 1 of them phase 3. Of 18 finished, 6 (33%) have results posted.
Among the 22 studies in Prostatic Neoplasms by Lantheus Holdings, Inc., this one is the 2nd largest by planned enrollment of the 20 interventional ones that give a count, is the only one that started in 2026, is one of 2 in phase 2/3, and was the 22nd registered.
Lantheus Holdings, Inc.’s Prostatic Neoplasms studies by the year they started, since 2008.
2 of the studies testing Gallium-68 in Prostatic Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07689656Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyA Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer | 2026-12-30 |
| NCT07781852Lumina Pharmaceuticals IncEvaluation of the Distribution of 64Cu/68Ga Labeled CM500 in Healthy Volunteers and Patients With Cancer | 2027-09-01 |
Add all 2 to your calendar (.ics) → With an account.
Among the 11 studies testing Gallium-68 in Prostatic Neoplasms, from their registry updates:
Among Lantheus Holdings, Inc.’s 22 in Prostatic Neoplasms:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Phase 2 Dose Optimization Period During the Phase 2 period, participants will receive 5 (±1) mCi (148 to 222 MBq) of [68Ga]-LNTH-2401 for PET/CT imaging with the primary objectives of determining the optimal administered activity, imaging parameters and tissue dosimetry. 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. Data from 6 eligible participants with GRPR-positive lesion(s) will be used to determine the optimal administered activity and imaging time window for Phase 3, with the possibility of enrolling additional participants if warranted. Dosimetry will be estimated from imaging data collected during the dose optimization period and analyzed using standard, validated methodologies appropriate for PET radiopharmaceuticals. Dosimetry calculations will be performed using Organ Level Internal Dose Assessment (OLINDA). Image quality evaluation will include qualitative assessment by qualified image readers and quantitative assessment of tumor-to-background characteristics for lesions identified on PET/CT. Lesion(s) demonstrating uptake consistent with GRPR expression may be evaluated to support assessment of lesion conspicuity, contrast, and interpretability across evaluated imaging parameters. These exploratory evaluations will be used solely to support selection of the optimized administered activity and imaging time window. Phase 2 dosimetry, biodistribution, and image quality assessment data will not contribute to the Phase 3 primary diagnostic performance analyses.
Phase 3 Diagnostic Performance Period The Phase 3 Diagnostic Performance Period is designed to evaluate the diagnostic accuracy of[68Ga]-LNTH-2401 PET/CT for detecting prostate cancer in pelvic lymph nodes (primary; compared to histopathology) and in other anatomic regions, as defined by study endpoints. All Phase 3 participants will undergo [68Ga]-LNTH-2401 PET/CT imaging using the optimized administered activity and imaging time window selected in Phase 2. Diagnostic accuracy will be assessed using local histopathological evaluation of surgically removed pelvic lymph nodes, or other anatomic regions (as applicable) as the primary standard of truth (SOT). The primary diagnostic performance endpoints are participant-level sensitivity and participant-level specificity of [68Ga]-LNTH-2401 PET/CT for detection of prostate cancer in pelvic lymph nodes, derived from pelvic lymph node region-level classifications compared with region-matched histopathology.
Secondary diagnostic performance assessments will use a composite standard of truth (CSOT) incorporating histopathology and, where applicable, anatomic correlation with conventional imaging modalities and/or PSMA PET imaging. All imaging data will be reviewed by 3 blinded central readers, and the CSOT will be established by an Independent Committee in accordance with a predefined charter.
Additionally, safety and tolerability will be evaluated following administration of [⁶⁸Ga]-LNTH-2401 using the Phase 2-selected imaging parameters. Regional detection performance across anatomic sites and assessment of the impact of [68Ga]-LNTH-2401 PET/CT imaging on intended clinical management will also be explored in the Phase 3 portion of the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the criteria below as defined to be enrolled in the study.
Participants who are sexually active must agree to the following during the study and for 7 days after last administration of study drug:
Adequate organ function, defined as follows:
Bone marrow reserve:
Liver function:
Renal function:
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.
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:
Exclusion Criteria:
Participants meeting any of the following exclusion criteria are not eligible for this study.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Phase 2 period, \[68Ga\]-LNTH-2401 will be administered at 5 (±1) mCi (148 to 222 MBq). Phase 3 period, the intended commercial-use manufactured \[68Ga\]-LNTH 2401 product will be administered for imaging at the optimized dose selected from the Phase 2 period.
Drug: [68Ga]-LNTH-2401
\[68Ga\]-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
Time frame: Day 1
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
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: 1 week (Ph2), 6 months (Ph3)
Safety and tolerability of [68Ga] LNTH 2401 in participants with either newly diagnosed or BCR PCa.
Clinical laboratory parameters (e.g., hematology, chemistry), vital signs, and ECG parameters after administration of \[68Ga\]-LNTH 2401.
Time frame: 1 week (Ph2), 6 months (Ph3)
Phase 3 Diagnostic Performance Period- Diagnostic accuracy (sensitivity and specificity) of [68Ga]-LNTH-2401 PET/CT imaging for detecting prostate cancer in pelvic lymph nodes, compared to histopathology.
Co-primary endpoints of: Participant-level specificity (TN/\[TN + FP\]) of \[68Ga\]-LNTH-2401 PET/CT for detection of prostate cancer in pelvic lymph nodes relative to histopathology. Participant-level sensitivity (TP/\[TP + FN\]) of \[68Ga\]-LNTH-2401 PET/CT for detection of prostate cancer in pelvic lymph nodes relative to histopathology.
Time frame: Enrollment through study completion, average 6 months
Phase 2 Dose Optimization Period- Refine the GRPR positivity definition
Prior and newly collected radioactivity uptake data (e.g., SUVmean, SUVmax ranges)
Time frame: Day 1
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.
Time frame: From Enrollment to End of treatment of Ph3
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.
Time frame: From Enrollment to End of treatment of Ph3
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.
Time frame: From Enrollment to End of treatment of Ph3
Phase 3 Diagnostic Performance Period- To determine the patient level and region level diagnostic performance of [68Ga] LNTH-2401 PET/CT imaging prostate cancer within the pelvic lymph nodes or other metastatic lesions.
PPV and NPV of \[68Ga\]-LNTH-2401 PET/CT imaging for prostate cancer relative to the composite SOT.
Time frame: From Enrollment to End of treatment of Ph3
Phase 3 Diagnostic Performance Period- To assess the impact of [68Ga]-LNTH-2401 PET/CT imaging on intended clinical management plans.
Proportion of participants with any change in intended clinical management plan from pre-dose to post-dose \[68Ga\]-LNTH-2401 PET/CT, based on a review of clinical and radiographic participant data, and captured by the treating physician using a structured Medical Management Questionnaire (MMQ).
Time frame: From Enrollment to 6 months follow-up
Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.
Of 43 phase 2/3 interventional studies under Prostatic Neoplasms, half reached primary completion within 115 months of starting (the median), counting those still running; a quarter within 32. This study's planned 36 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Gallium-68