99mTc-MIP-1404 SPECT/CT in Primary Staging of Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PSMA-imaging.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
99mTc-MIP-1404 SPECT/CT for Primary PROstate Cancer STAging: Comparative Prospective, Randomized Trial to Present Guideline Imaging
Overview
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).
Interventions
- Diagnostic test PSMA-imaging
Subjects undergo additional imaging i.e. PSMA/SPECT/CT and PSMA/PET/CT
Primary outcome measures
- Number of subjects with local lymph node metastasi(e)s [Time frame: Baseline]
Secondary outcome measures (11)
- Number of subjects with metastasis [Time frame: Baseline]
- Diagnostic accuracy of detecting subjects with metastasis between PSMA-SPECT/CT and conventional imaging [Time frame: Baseline]
- True positive rate in lesion level between PSMA-SPECT/CT and conventional imaging [Time frame: Baseline]
- False positive rate in lesion level between PSMA-SPECT/CT and conventional imaging [Time frame: Baseline]
- False negative rate in lesion level between PSMA-SPECT/CT and conventional imaging [Time frame: Baseline]
- Diagnostic accuracy of detecting subjects with metastasis between PSMA-SPECT/CT and PSMA-PET/CT [Time frame: Baseline]
- True positive rate in lesion level between PSMA-SPECT/CT and PSMA-PET/CT [Time frame: Baseline]
- False positive rate in lesion level between PSMA-SPECT/CT and PSMA-PET/CT [Time frame: Baseline]
- False negative rate in lesion level between PSMA-SPECT/CT and PSMA-PET/CT [Time frame: Baseline]
- Inter-rater agreement [Time frame: Baseline]
- Effect on treatment decision [Time frame: Baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Finland · 1 center
- University Hospital of Turku, Hospital Distric of Southwest Finland — Turku
Identifiers
NCT: NCT06219746 · T19/2021