Clinical trial NCT06219746: 99mTc-MIP-1404 SPECT/CT in Primary Staging of Prostate Cancer
Official title: 99mTc-MIP-1404 SPECT/CT for Primary PROstate Cancer STAging: Comparative Prospective, Randomized Trial to Present Guideline Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: PSMA
PET
SPECT
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-23
Enrollment: 320
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Primary outcomes:
measure: Number of subjects with local lymph node metastasi(e)s
timeFrame: Baseline
Secondary outcomes:
measure: Number of subjects with metastasis
timeFrame: Baseline
measure: Diagnostic accuracy of detecting subjects with metastasis between PSMA-SPECT/CT and conventional imaging
timeFrame: Baseline
measure: True positive rate in lesion level between PSMA-SPECT/CT and conventional imaging
timeFrame: Baseline
measure: False positive rate in lesion level between PSMA-SPECT/CT and conventional imaging
timeFrame: Baseline
measure: False negative rate in lesion level between PSMA-SPECT/CT and conventional imaging
timeFrame: Baseline
measure: Diagnostic accuracy of detecting subjects with metastasis between PSMA-SPECT/CT and PSMA-PET/CT
timeFrame: Baseline
measure: True positive rate in lesion level between PSMA-SPECT/CT and PSMA-PET/CT
timeFrame: Baseline
measure: False positive rate in lesion level between PSMA-SPECT/CT and PSMA-PET/CT
timeFrame: Baseline
measure: False negative rate in lesion level between PSMA-SPECT/CT and PSMA-PET/CT
timeFrame: Baseline
measure: Inter-rater agreement
timeFrame: Baseline
measure: Effect on treatment decision
timeFrame: Baseline
Other outcomes:
measure: PSMA only lesions
timeFrame: Baseline
measure: ctDNA
timeFrame: Baseline
measure: Gut microbiota
timeFrame: Baseline
measure: Optimization of 99mTc-MIP-1404 SPECT/CT imaging protocol
timeFrame: Baseline
Locations:
city: Turku
country: Finland
facility: University Hospital of Turku, Hospital Distric of Southwest Finland
state: Southwest Finland
Study officials:
affiliation: Turku University Hospital
name: Otto O Ettala
role: PRINCIPAL_INVESTIGATOR
References: