Using 99mTc-MIP-1404 SPECT/CT for staging prostate cancer
99mTc-MIP-1404 SPECT/CT for Primary PROstate Cancer STAging: Comparative Prospective, Randomized Trial to Present Guideline Imaging
NA · Turku University Hospital · NCT06219746
This study is testing a new imaging technique using a special substance to see if it can give better information about the spread of prostate cancer in high-risk patients compared to standard methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Turku University Hospital (other gov) |
| Locations | 1 site (Turku, Southwest Finland) |
| Trial ID | NCT06219746 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 99mTc-MIP-1404 SPECT/CT imaging in the primary staging of prostate cancer, particularly in high-risk patients. The approach involves administering a single intravenous bolus of 99mTc-MIP-1404, which binds to the PSMA molecule, allowing for enhanced imaging of potential metastases. The goal is to improve the accuracy of staging compared to traditional methods like bone scintigraphy and contrast-enhanced CT scans, which have lower sensitivity for detecting metastasis. By providing more reliable staging information, this study aims to inform treatment decisions for patients diagnosed with prostate cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are male patients aged 18 years or older with histopathologically confirmed high-risk prostate cancer.
Not a fit: Patients with a history of drug or alcohol use that may interfere with study adherence or those who have undergone androgen deprivation therapy prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to more accurate staging of prostate cancer, improving treatment decisions and potentially outcomes for patients.
How similar studies have performed: While the use of PSMA imaging is gaining traction, this specific application of 99mTc-MIP-1404 SPECT/CT in primary staging is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol * Subjects must be male, aged 18 years or above at Baseline * Histopathologically confirmed high risk (Gleason ≥4+4, PSA ≥20 and/ or cT≥3a) acinar or ductal adenocarcinoma of prostate Exclusion Criteria: * Allergy/sensitivity to study medications or their ingredients * Subjects unable to provide written informed consent * Subjects who have any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study. * Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements. * Subjects who have androgen deprivation therapy initiated before enrolment * Subjects who have claustrophobia
Where this trial is running
Turku, Southwest Finland
- University Hospital of Turku, Hospital Distric of Southwest Finland — Turku, Southwest Finland, Finland (RECRUITING)
Study contacts
- Principal investigator: Otto O Ettala — Turku University Hospital
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, PSMA, PET, SPECT