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

NCT06219746 | Recruiting

• 1 other identifier: T19/2021
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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

Keywords

PSMA; PET; SPECT

Outcome Measures

Primary Outcomes (1)

• Number of subjects with local lymph node metastasi(e)s

  Superiority of experimental arm (99mTc-MIP-1404 SPECT/CT) in detecting subjects with local lymph node metastasi(e)s compared to control arm (ce-wbCT)

  Baseline

Secondary Outcomes (11)

• Number of subjects with metastasis

  Baseline

• Diagnostic accuracy of detecting subjects with metastasis between PSMA-SPECT/CT and conventional imaging

  Baseline

• True positive rate in lesion level between PSMA-SPECT/CT and conventional imaging

  Baseline

• False positive rate in lesion level between PSMA-SPECT/CT and conventional imaging

  Baseline

• False negative rate in lesion level between PSMA-SPECT/CT and conventional imaging

  Baseline

Other Outcomes (4)

• PSMA only lesions

  Baseline

• ctDNA

  Baseline

• Gut microbiota

  Baseline

Study Arms (2)

Control arm

NO INTERVENTION

Subjects undergo bone scintigraphy and whole body CT

Experimental arm

EXPERIMENTAL

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

Diagnostic Test: PSMA-imaging

Interventions

PSMA-imaging DIAGNOSTIC_TEST

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

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

University Hospital of Turku, Hospital Distric of Southwest Finland

Turku, Southwest Finland, 20521, Finland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Otto O Ettala

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: January 23, 2024
• Study Start: June 1, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)