NCT06219746 99mTc-MIP-1404 SPECT/CT in Primary Staging of Prostate Cancer
| NCT ID | NCT06219746 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Turku University Hospital |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 320 participants in total. It began in 2022-06-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prostate cancer (PCa) is currently the most common cancer in men in Finland (www.cancerregistry.fi). Although prognosis is very good in majority of men, it is noteworthy that still up to 20% of PCa cases are metastatic at the time of initial diagnosis and yearly 900 men die because of prostate cancer. Robust primary staging is, therefore, one of the most important prognostic factors, and it is crucial for treatment decision. Despite their low sensitivity to detect metastasis, bone scintigraphy (BS) and contrast enhanced whole body computed tomography (ce-wbCT) are recommended by current guidelines for primary staging in men at risk of metastasis. MIP-1404 is a small-molecule PSMA inhibitor that can be used in SPECT systems (99mTc-MIP- 1404 SPECT/CT). 99mTc-MIP-1404 SPECT/CT is performed by a single IV bolus of 99mTc-MIP-1404, which binds with high affinity to extracellular domain of PSMA molecule. As of March 2020, a total of 629 subjects have received 99mTc-MIP-1404 injection averaging 740 ±111 MBq (20 ± 3 mCi) per administration in prospective clinical trials. 99mTc MIP-1404 has been well tolerated following a single IV dose at 740 ± 111 MBq in both healthy volunteers and patients with confirmed metastatic prostate adenocarcinoma. In prospective and retrospective studies, it has shown high potential to detect prostate cancer lesions in primary staging. In fact, Goffin et al. reported a sensitivity of 50% and specificity of 87% detecting local lymph node metastasis in radically operated patients when histopathology was used as a reference. This corresponds closely to the sensitivity of PSMA-PET. PROSTAMIP is a randomized prospective single-institutional study to demonstrate superiority of 99mTc-MIP-1404 SPECT/CT compared to traditional imaging modalities (99mTc-HMDP planar BS plus ce-wbCT).
Eligibility 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
Contact & Investigator
Otto O Ettala
PRINCIPAL INVESTIGATOR
Turku University Hospital
Frequently Asked Questions
Who can join the NCT06219746 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06219746 currently recruiting?
Yes, NCT06219746 is actively recruiting participants. Visit ClinicalTrials.gov or contact Turku University Hospital to inquire about joining.
Where is the NCT06219746 trial being conducted?
This trial is being conducted at Turku, Finland.
Who is sponsoring the NCT06219746 clinical trial?
NCT06219746 is sponsored by Turku University Hospital. The principal investigator is Otto O Ettala at Turku University Hospital. The trial plans to enroll 320 participants.
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