Prostate spesific membrane antigen single photon emission computed tomography in staging of prostate cancer: a randomised trial

99mTc-MIP-1404 SPECT/CT for primary PROstate cancer STAging: comparative prospective, randomized trial to present guideline imaging

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000486-33-FI

Enrollment

320

Registered

2022-02-18

Start date

2022-03-21

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

Product Name: 99mTc-MIP-1404 Pharmaceutical Form: Kit for radiopharmaceutical preparation INN or Proposed INN: Technetium (99mTc) trofolastat chloride CAS Number: 1333126-69-4 Concentration unit: MBq

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Histopathologically confirmed high risk (Gleason =4+4, PSA =20 and/ or cT=3a) acinar or ductal adenocarcinoma of prostate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 160

Exclusion criteria

Exclusion criteria: Subjects who are previously treated due to prostate cancer

Design outcomes

Primary

Measure	Time frame
Main Objective: 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);Secondary Objective: i)Comparison of detection of metastatic subjects (local lymph node metastasis and/ or distant metastasis) between experimental arm (99mTc-MIP-1404 SPECT/CT) and control arm (a combination of 99mTc-HMDP planar BS and ce-wbCT) ii)Comparison of detection of subjects with bone metastasis between experimental arm (99mTc-MIP-1404 SPECT/CT) and control arm (a combination of 99mTc-HMDP planar BS and ce-wbCT) iii)Comparison of diagnostic accuracy between 99mTc-MIP-1404 SPECT/CT, 18F-PSMA-1007 PET/CT, 18F-DCFPyl-PSMA PET/CT, and bi-parametric prostate MRI in local tumor assessment iv)Comparison of diagnostic accuracy between ce-wbCT, 99mTc-MIP-1404 SPECT/CT, 18F-PSMA-1007 PET/CT, 18F-DCFPyl-PSMA PET/CT, and bi-parametric prostate MRI in detection of subjects with local lymph node metastasis ;Primary end point(s): The proportion of subjects with local lymph node metastasi(e)s in control and experimental arms reported by ce-wbCT reader 1 and 99Tc-MIP-1404 SPECT/CT reader 1 respectively;Timepoint(s) of evaluation of this end point: baseline	—

Measure

Time frame

Main Objective: 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);Secondary Objective: i)Comparison of detection of metastatic subjects (local lymph node metastasis and/ or distant metastasis) between experimental arm (99mTc-MIP-1404 SPECT/CT) and control arm (a combination of 99mTc-HMDP planar BS and ce-wbCT) ii)Comparison of detection of subjects with bone metastasis between experimental arm (99mTc-MIP-1404 SPECT/CT) and control arm (a combination of 99mTc-HMDP planar BS and ce-wbCT) iii)Comparison of diagnostic accuracy between 99mTc-MIP-1404 SPECT/CT, 18F-PSMA-1007 PET/CT, 18F-DCFPyl-PSMA PET/CT, and bi-parametric prostate MRI in local tumor assessment iv)Comparison of diagnostic accuracy between ce-wbCT, 99mTc-MIP-1404 SPECT/CT, 18F-PSMA-1007 PET/CT, 18F-DCFPyl-PSMA PET/CT, and bi-parametric prostate MRI in detection of subjects with local lymph node metastasis ;Primary end point(s): The proportion of subjects with local lymph node metastasi(e)s in control and experimental arms reported by ce-wbCT reader 1 and 99Tc-MIP-1404 SPECT/CT reader 1 respectively;Timepoint(s) of evaluation of this end point: baseline

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Secondary

Measure	Time frame
Secondary end point(s): i) The proportion of metastatic (local lymph node and/ or distant metastasis) subjects in control (a combination of 99mTc-HMDP planar BS and ce-wbCT) and experimental arm (99mTc-MIP-1404 SPECT/CT) ii) The proportion of subjects with bone metastasis in control (a combination of 99mTc-HMDP planar BS and ce-wbCT) and in experimental arm (99mTc-MIP-1404 SPECT/CT) iii) Sensitivity, specificity, accuracy, and AUC of 99mTc-MIP-1404 SPECT/CT, 18F-PSMA-1007 PET/CT, 18F-DCFPyl-PSMA PET/CT, and bi-parametric prostate MRI detecting local tumor in prostate, extracapsular extension and seminal vesicle invasion in intervention arm. iv) Sensitivity, specificity, accuracy, and AUC of ce-wbCT, 99mTc-MIP-1404 SPECT/CT, 18F-PSMA-1007 PET/CT, 18F-DCFPyl-PSMA PET/CT, and bi-parametric prostate MRI detecting subjects with local lymph node metastasis in intervention arm;Timepoint(s) of evaluation of this end point: all baseline	—

Measure

Time frame

Secondary end point(s): i) The proportion of metastatic (local lymph node and/ or distant metastasis) subjects in control (a combination of 99mTc-HMDP planar BS and ce-wbCT) and experimental arm (99mTc-MIP-1404 SPECT/CT) ii) The proportion of subjects with bone metastasis in control (a combination of 99mTc-HMDP planar BS and ce-wbCT) and in experimental arm (99mTc-MIP-1404 SPECT/CT) iii) Sensitivity, specificity, accuracy, and AUC of 99mTc-MIP-1404 SPECT/CT, 18F-PSMA-1007 PET/CT, 18F-DCFPyl-PSMA PET/CT, and bi-parametric prostate MRI detecting local tumor in prostate, extracapsular extension and seminal vesicle invasion in intervention arm. iv) Sensitivity, specificity, accuracy, and AUC of ce-wbCT, 99mTc-MIP-1404 SPECT/CT, 18F-PSMA-1007 PET/CT, 18F-DCFPyl-PSMA PET/CT, and bi-parametric prostate MRI detecting subjects with local lymph node metastasis in intervention arm;Timepoint(s) of evaluation of this end point: all baseline

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Countries

Finland

Contacts

Public ContactTurku University Hospital

Turku University Hospital

otto.ettala@tyks.fi+35823130000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026