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

2024-516083-28-00 Phase II and Phase III (Integrated) Ongoing, recruiting

Start 1 Jun 2022 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)
Status Ongoing, recruiting
Participants planned 320
Countries 1
Sites 1

Prostate cancer

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)

Key facts

Sponsor
Turku University Hospital
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male
Therapeutic area
Diseases [C] - Male Urogenital Diseases [C12], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trial duration
1 Jun 2022 → ongoing
Decision date (initial)
2024-12-20
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-516083-28-00
EudraCT number
2021-000486-33
ClinicalTrials.gov
NCT06219746

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Diagnosis

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 objectives 8

  1. 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)
  2. 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)
  3. 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
  4. Comparison of diagnostic accuracy between ce-wbCT, 99mTc-MIP-1404 SPECT/CT, 18FPSMA- 1007 PET/CT, 18F-DCFPyl-PSMA PET/CT, and bi-parametric prostate MRI in detection of subjects with local lymph node metastasis
  5. Comparison of diagnostic accuracy between a combination of 99mTc-HMDP planar BS and ce-wbCT, 99mTc-MIP-1404 SPECT/CT, 18F-PSMA-1007 PET/CT, and 18F-DCFPyl-PSMA PET/CT in detection of metastatic subjects (a combination of nodal and distant metastasis)
  6. Description of true positive, false positive, and false negative rates between a combination of 99mTc-HMDP planar BS and ce-wbCT, 99mTc-MIP-1404 SPECT/CT, and 18F-PSMA-1007 PET/CT in lesion level
  7. Inter-rater agreement between the two readers in each imaging modality
  8. Characterization of the effect of 99mTc-MIP-1404 SPECT/CT, and 18F-PSMA-1007 PET/CT on treatment decision compared to conventional imaging

Conditions and MedDRA coding

Prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
  2. Subjects must be male, aged 18 years or above at Baseline
  3. Histopathologically confirmed high risk (Gleason ≥4+4, PSA ≥20 and/ or cT≥3a) acinar or ductal adenocarcinoma of prostate
  4. Subjects without histopathological verification of prostate cancer but with very high suspicion of prostate cancer based on PSA, clinical findings or symptoms. However, histopathological verification should be obtained after the inclusion.

Exclusion criteria 6

  1. Allergy/sensitivity to study medications or their ingredients
  2. Subjects unable to provide written informed consent
  3. 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
  4. Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
  5. Subjects who have androgen deprivation therapy initiated before enrolment. However, initiation of androgen deprivation therapy is allowed 2-3 weeks before study related imaging if clinically relevant especially in patients with high suspicion of metastatic disease based on PSA, clinical findings or symptoms.
  6. Subjects who have claustrophobia

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 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

Secondary endpoints 8

  1. 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 arms (99mTc-MIP-1404 SPECT/CT)
  2. 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)
  3. 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
  4. Sensitivity, specificity, accuracy, and AUC of ce-wbCT, 99mTc-MIP-1404 SPECT/CT, 18FPSMA- 1007 PET/CT, 18F-DCFPyl-PSMA PET/CT, and bi-parametric prostate MRI detecting subjects with local lymph node metastasis in intervention arm
  5. Sensitivity, specificity, accuracy, and AUC of a combination of 99mTc-HMDP planar BS and ce-wbCT, 99mTc-MIP-1404 SPECT/CT, 18F-PSMA-1007 PET/CT, and 18F-DCFPyl- PSMA PET/CT detecting subjects with bone metastasis in intervention arm
  6. The number of true positive, false positive, and false negative lesions in a combination of 99mTc-HMDP planar BS and ce-wbCT, 99mTc-MIP-1404 SPECT/CT, 18FPSMA- 1007 PET/CT, and 18F-DCFPyl-PSMA PET/CT in intervention arm
  7. Cohen’s Kappa between the two readers in each modality
  8. The number and proportion of subjects in which treatment recommendation was changed due to 99mTc-MIP 1404 SPECT/CT or 18F-PSMA-1007 PET/CT

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

99mTc-MIP-1404

PRD11786428 · Product

Active substance
Trofolastat
Substance synonyms
MIP-1404, (2S)-2-[[(1S)-4-[[(1S)-5-[Bis[[1-[2-[bis(carboxymethyl)amino]-2-oxoethyl]imidazol-2-yl]methyl]amino]-1-carboxypentyl]amino]-1-carboxy-4-oxobutyl]carbamoylamino]pentanedioic acid
Pharmaceutical form
KIT FOR RADIOPHARMACEUTICAL PREPARATION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
814 MBq megabecquerel(s)
Max total dose
814 MBq megabecquerel(s)
Max treatment duration
1 Day(s)
Authorisation status
Not Authorised
ATC code
V09IA — TECHNETIUM (99MTC) COMPOUNDS
MA holder
TURKU UNIVERSITY HOSPITAL
Paediatric formulation
No
Orphan designation
No

Comparator 2

18F-PSMA-1007

SUB208557 · Substance

Active substance
18F-PSMA-1007
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
250 MBq megabecquerel(s)
Max total dose
250 MBq megabecquerel(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
please see MET-documentation

Pylclari 1 000 MBq/mL solution for injection

PRD10810414 · Product

Active substance
Piflufolastat (18F)
Substance synonyms
N-[[[(1S)-1-Carboxy-5-[[[6-(fluoro-18F)-3-pyridinyl]carbonyl]amino]pentyl]amino]carbonyl]-L-glutamic acid, Piflufolastat F18, 2-(3-(1-carboxy-5-[(6-[18F]fluoropyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic acid, DCFPyL F-18, 18F-DCFPyL
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
327.1 MBq megabecquerel(s)
Max total dose
327.1 MBq megabecquerel(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
V09IX16 — -
Marketing authorisation
EU/1/23/1746/001
MA holder
CURIUM PET FRANCE
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Turku University Hospital

15 Total trials 6 Recruiting
Academic / Non-commercial
Sponsor organisation
Turku University Hospital
Address
Kiinamyllynkatu 4-8
City
Turku
Postcode
20520
Country
Finland

Scientific contact point

Organisation
Turku University Hospital
Contact name
Otto Ettala

Public contact point

Organisation
Turku University Hospital
Contact name
Otto Ettala

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Finland Ongoing, recruiting 320 1
Rest of world — 0 —

Investigational sites

Finland

1 site · Ongoing, recruiting
Turku University Hospital
Urology, Kiinamyllynkatu 4-8, 20520, Turku

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Finland 2022-06-01 2022-06-01

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) PROSTAMIP tutkimussuunnitelma v2 2
Recruitment arrangements (for publication) PROSTAMIP_Selvitys rekrytoinnista 1
Subject information and informed consent form (for publication) PROSTAMIP suostumus v1 1
Subject information and informed consent form (for publication) PROSTAMIP tiedote v2 2
Summary of Product Characteristics (SmPC) (for publication) 12_MET5545 1
Summary of Product Characteristics (SmPC) (for publication) pylclari-epar-product-information_en 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-12-13 Finland Acceptable
2024-12-20
 2024-12-20

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