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

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

NCT ID: NCT06219746

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
PSMA
PET
SPECT

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: PSMA-imaging
Description: Subjects undergo additional imaging i.e. PSMA/SPECT/CT and PSMA/PET/CT
Arm group label: Experimental arm

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).

Criteria for 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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital of Turku, Hospital Distric of Southwest Finland

Address:
City: Turku
Zip: 20521
Country: Finland

Status: Recruiting

Contact:
Last name: Otto O Ettala, MD, PhD

Phone: 23130280

Phone ext: +358
Email: otto.ettala@varha.fi

Start date: June 1, 2022

Completion date: December 31, 2026

Lead sponsor:
Agency: Turku University Hospital
Agency class: Other

Source: Turku University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06219746