NCT06219746RecruitingPhase 2/3
99mTc-MIP-1404 SPECT/CT in Primary Staging of Prostate Cancer
99mTc-MIP-1404 SPECT/CT for Primary PROstate Cancer STAging: Comparative Prospective, Randomized Trial to Present Guideline Imaging
Source: ClinicalTrials.gov · Last updated 23 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 3 Nov 2023
- Start date
- 1 Jun 2022
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Turku University Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06219746
- EU CT number
- 2024-516083-28-00
- EudraCT number
- 2021-000486-33
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 320
- From 1 Jun 2022 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who have androgen deprivation therapy initiated before enrolment
Other illness
- Allergy/sensitivity to study medications or their ingredients
- 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.
Other
- Subjects unable to provide written informed consent
- Subjects who have claustrophobia
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.