Trofolastat for Prostate cancer

Inclusion criteria

• {"criterion_text":"- Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol"}
• {"criterion_text":"- Subjects must be male, aged 18 years or above at Baseline"}
• {"criterion_text":"- Histopathologically confirmed high risk (Gleason ≥4+4, PSA ≥20 and/ or cT≥3a) acinar or ductal adenocarcinoma of prostate"}
• {"criterion_text":"- 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

• {"criterion_text":"- Allergy/sensitivity to study medications or their ingredients"}
• {"criterion_text":"- Subjects unable to provide written informed consent"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Subjects who have claustrophobia"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion of subjects with local lymph node metastases as detected/reported by reader 1 for each imaging modality (ce-wbCT for control; 99mTc-MIP-1404 SPECT/CT for experimental). Detection as assessed by specified image reader(s)."}

Secondary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Proportion of subjects identified as metastatic (nodal and/or distant) by the specified imaging strategies in each arm."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Proportion of subjects with bone metastases as detected by the indicated imaging methods in each arm."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Diagnostic performance metrics (sensitivity, specificity, accuracy, AUC) for listed imaging modalities in detecting local tumor features; assessed against reference/standard as defined in study (readers' assessments)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Diagnostic performance metrics for listed modalities in detecting subjects with local lymph node metastasis, as assessed by readers."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Diagnostic performance metrics for listed modalities/combinations in detecting bone metastasis."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Lesion-level counts of true positives, false positives, and false negatives for each imaging approach in the intervention arm."}
• {"endpoint_text":"- Cohen’s Kappa between the two readers in each modality","definition_or_measurement_approach":"Inter-rater agreement (Cohen's Kappa) between two image readers for each imaging modality."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Count and proportion of subjects whose treatment recommendation changed as a result of findings from the specified imaging modalities."}

Finland

Earliest CTIS Part Ii Submission Date

02-07-2024

Latest Decision Or Authorization Date

20-12-2024

Processing Time Days

171

Number Of Sites

1

Number Of Participants

320

Primary sponsor

Full Name

Turku University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland