99mTc-MIP-1404 SPECT/CT in Primary Staging of Prostate Cancer

NCT ID: NCT06219746

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2026-12-31

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).

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control arm

Subjects undergo bone scintigraphy and whole body CT

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental arm

Subjects undergo bone scintigraphy, whole body CT, 99mTc-MIP-1404 SPECT/CT, and 18F- PSMA-1007 PET/CT

Group Type: EXPERIMENTAL

PSMA-imaging

Intervention Type: DIAGNOSTIC_TEST

Subjects undergo additional imaging i.e. PSMA/SPECT/CT and PSMA/PET/CT

Interventions

PSMA-imaging

Subjects undergo additional imaging i.e. PSMA/SPECT/CT and PSMA/PET/CT

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Otto Ettala

Adjunct professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Otto O Ettala

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

University Hospital of Turku, Hospital Distric of Southwest Finland

Turku, Southwest Finland, Finland

Site Status: RECRUITING

Countries

Finland

Facility Contacts

Otto O Ettala, MD, PhD

Role: primary

otto.ettala@varha.fi

23130280 ext. +358

Other Identifiers

T19/2021

Identifier Type: -

Identifier Source: org_study_id