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99mTc-MIP-1404 SPECT/CT for primary PROstate cancer STAging: comparative prospective, randomized trial to present guideline imaging, PROSTAMIP
EU CTIS ID: 2024-516083-28-00
What this study is testing
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)
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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
- 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.
You likely can't join 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. 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.
- Subjects who have claustrophobia
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.