Prostate CancerNCT06219746
99mTc-MIP-1404 SPECT/CT in Primary Staging of Prostate Cancer
A study testing PSMA-imaging in people with Prostate Cancer, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSMA-imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jun 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
University Hospital of Turku, Hospital Distric of Southwest Finland
Turku, Southwest Finland, 20521
Otto O Ettala, MD, PhD, 23130280 ext. +358, otto.ettala@varha.fi
About this study
Official title: 99mTc-MIP-1404 SPECT/CT for Primary PROstate Cancer STAging: Comparative Prospective, Randomized Trial to Present Guideline Imaging
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
- Being tested
- PSMA-imaging
- Keywords
- PSMA, PET, SPECT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA-imagingDiagnostic test
Subjects undergo additional imaging i.e. PSMA/SPECT/CT and PSMA/PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: PSMA-imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Secondary outcomes (11)
Number of subjects with metastasis
Comparison of detection of metastatic subjects (local lymph node metastasis and/ or distant metastasis) in experimental arm (99mTc-MIP-1404 SPECT/CT) and in control arm (a combination of 99mTc-HMDP planar bone scintigraphy and contract enhanced CT)
Measured: Baseline
Diagnostic accuracy of detecting subjects with metastasis between PSMA-SPECT/CT and conventional imaging
Comparison of diagnostic accuracy between PSMA-SPECT/CT and conventional imaging (a combination of 99mTc-HMDP planar BS and ce-wbCT) in detection of metastatic subjects (a combination of nodal and distant metastasis)
Measured: Baseline
True positive rate in lesion level between PSMA-SPECT/CT and conventional imaging
Description of true positive rate of metastatic lesions between PSMA-SPECT/CT and conventional imaging (a combination of 99mTc-HMDP planar bone scintigraphy and contrast enhanced)
Measured: Baseline
False positive rate in lesion level between PSMA-SPECT/CT and conventional imaging
Description of false positive rate of metastatic lesions between PSMA-SPECT/CT and conventional imaging (a combination of 99mTc-HMDP planar bone scintigraphy and contrast enhanced)
Measured: Baseline
False negative rate in lesion level between PSMA-SPECT/CT and conventional imaging
Description of false negative rate of metastatic lesions between PSMA-SPECT/CT and conventional imaging (a combination of 99mTc-HMDP planar bone scintigraphy and contrast enhanced)
Measured: Baseline
Diagnostic accuracy of detecting subjects with metastasis between PSMA-SPECT/CT and PSMA-PET/CT
Comparison of diagnostic accuracy between PSMA-SPECT/CT and PSMA-PET/CT in detection of metastatic subjects (a combination of nodal and distant metastasis)
Measured: Baseline
True positive rate in lesion level between PSMA-SPECT/CT and PSMA-PET/CT
Description of true positive rate of metastatic lesions between PSMA-SPECT/CT and PSMA-PET/CT
Measured: Baseline
False positive rate in lesion level between PSMA-SPECT/CT and PSMA-PET/CT
Description of false positive rate of metastatic lesions between PSMA-SPECT/CT and PSMA-PET/CT
Measured: Baseline
False negative rate in lesion level between PSMA-SPECT/CT and PSMA-PET/CT
Description of false negative rate of metastatic lesions between PSMA-SPECT/CT and PSMA-PET/CT
Measured: Baseline
Inter-rater agreement
Cohen´s Kappa value between the two readers in each imaging modality
Measured: Baseline
Effect on treatment decision
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Jun 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Otto Ettala, Turku University Hospital
- Investigators
- Otto O Ettala, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219746
- Sponsor's protocol ID
- T19/2021
- Status last verified
- Jan 2024
- First submitted
- 3 Nov 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 99mTc-MIP-1404 SPECT/CT for Primary PROstate Cancer STAging: Comparative Prospective, Randomized Trial to Present Guideline Imaging
- ClinicalTrials.gov ID
- NCT06219746
- Acronym / sponsor ID
- T19/2021
- Conditions
- Prostate Cancer
- Keywords
- PSMA, PET, SPECT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Subjects undergo bone scintigraphy and whole body CT |
| Experimental arm | Experimental | Diagnostic Test: PSMA-imagingSubjects undergo bone scintigraphy, whole body CT, 99mTc-MIP-1404 SPECT/CT, and 18F- PSMA-1007 PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA-imagingSubjects undergo additional imaging i.e. PSMA/SPECT/CT and PSMA/PET/CT | Diagnostic test | Experimental arm |
Primary outcome
Number of subjects with local lymph node metastasi(e)s
Time frame: Baseline
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)
11 secondary outcomes
Number of subjects with metastasis
Time frame: Baseline
Diagnostic accuracy of detecting subjects with metastasis between PSMA-SPECT/CT and conventional imaging
Time frame: Baseline
True positive rate in lesion level between PSMA-SPECT/CT and conventional imaging
Time frame: Baseline
False positive rate in lesion level between PSMA-SPECT/CT and conventional imaging
Time frame: Baseline
False negative rate in lesion level between PSMA-SPECT/CT and conventional imaging
Time frame: Baseline
Diagnostic accuracy of detecting subjects with metastasis between PSMA-SPECT/CT and PSMA-PET/CT
Time frame: Baseline
True positive rate in lesion level between PSMA-SPECT/CT and PSMA-PET/CT
Time frame: Baseline
False positive rate in lesion level between PSMA-SPECT/CT and PSMA-PET/CT
Time frame: Baseline
False negative rate in lesion level between PSMA-SPECT/CT and PSMA-PET/CT
Time frame: Baseline
Inter-rater agreement
Time frame: Baseline
Effect on treatment decision
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University Hospital of Turku, Hospital Distric of Southwest Finland
Turku, Finland
Otto O Ettala principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA-imaging in people with Prostate Cancer, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with local lymph node metastasi(e)s (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.