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A Phase 2/3,PSMA-T4, Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
[99mTc]Tc-PSMA-T4
Sponsored by
NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 18 years of age or older. PS ECOG < 2 Prior diagnosis of any type of prostate cancer with a Gleason score (GlS) above 6. Confirmatory prostate biopsy, pelvic MRI and bone scan within 1 month before screening Willingness to participate in this study and to obtain written informed consent. Additional inclusion criteria for each cohort: Cohort A: Intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer Greater than 10% chance of lymph node involvement assessed using the Memorial Sloan Kettering nomogram for probability of lymph node involvement in prostate cancer patients. Cohort B: High or very high-risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer Cohort C: Biochemical failure after radical prostatectomy defined as failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after RP with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence) OR biochemical failure after definitive radiotherapy based on Phoenix Consensus OR radiographic evidence of metastatic disease without PSA persistence/recurrence OR clinical symptoms suggesting distant metastases. Exclusion Criteria: No histopathological confirmation of prostate cancer. Patients with pacemakers or metal parts that prevent pelvic MRI to confirm the presence of prostate cancer. Infection with hepatitis B virus (including carriers) during screening, i.e. hepatitis B positive surface antigen (HBsAg) or positive hepatitis C (anti-HCV) antibody. Infected with acquired immunodeficiency (HIV). Abnormal liver function including a significant increase of liver enzymes like: ALAT, ASPAT, alkaline phosphatase (AP) greater than 5x upper limit normal (ULN) and an increase in bilirubin greater than 2xULN. Renal impairment including GFR <30 ml / min. Within 6 months before inclusion into the study: myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.); Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia), second or higher degree atrio-ventricular (AV) heart block. Cerebrovascular accident, transient ischemic attack, acute stroke etc. Subjects with pulmonary embolism or deep vein thrombosis have been reported within the last 6 months. An active infection that the investigator considers precluding the patient from being included in the study, such as urinary tract infections, respiratory tract infections, and diabetes infection within the diabetic foot with osteomyelitis.

Sites / Locations

  • GAMMED Centrum Diagnostyczno-LeczniczeRecruiting
  • Centrum Onkologii im. prof. F. ŁukaszczykaRecruiting
  • 4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Cohort A - lymph node assessment in intermediate risk group

Cohort B - general assessment (bone and lymph nodes) in high and very high-risk group

Cohort C - recurrent disease after definitive treatment (radiotherapy or surgery)

Arm Description

The patients will undergo [99mTc]Tc-PSMA-T4 semiWB- SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) with additional chest and abdominal CE computed tomography and [99mTc]Tc-MDP bone scan in unfavorable risk prostate cancer patients

The patients will undergo [99mTc]TcPSMA-T4 semi-WB- SPECT/CT and CE multiparametric MRI (according to PI-RADS 2.1 protocol), and chest and abdomen CE computed tomography, and skeletal scintigraphy ([99mTc]Tc-MDP bone scan).

The patients will undergo [99mTc]TcPSMA-T4 semiWB- SPECT/CT and the second confirmatory imaging modality or biopsy in the case of evidence on progressive disease (PSA persistence/recurrence or radiographic evidence of metastatic disease or clinical symptoms suggesting metastatic disease).

Outcomes

Primary Outcome Measures

Primary Endpoints
Clinical feasibility in each cohort: the diagnostic method will be deemed a feasible approach if at least 80% of participants in each cohort fulfil the criteria of sensitivity (true positive) and specificity (true negative) of PSMA-T4 WB-SPECT/CT - detection all lesions that are pathologically or radiologically confirmed or suspicious in other modalities recommended in a particular clinical situation by international guidelines for prostate cancer diagnosis and treatment ("golden standards" separate for each cohort). Feasibility = (number of patients with true positive and/or true negative without false positive and/or false negative results of PSMA-T4 WB-SPECT/CT x 100%) / all patients. The patients will undergo PSMA-T4 semiWB-SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) withadditional chest and abdominal CE computed tomography and[ 99m Tc]Tc-MDP bone scan in unfavorable risk prostate cancer patients.

Secondary Outcome Measures

Secondary Outcome Measures
Sensitivity(number of true positives x 100%)/(number of true positives + number of false negatives) Specificity:(number of true negatives x 100%)/(number of true negatives + number of false positives) Positive and negative predictive value: Positive predictive value defined as number of true positives x 100%/number of true positives + number of false positives. Negative predictive value defined as number of true negatives x 100%/number of true negatives + number of false negatives. The patients will undergo PSMA-T4 semiWB-SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) withadditional chest and abdominal CE computed tomography and[ 99m Tc]Tc-MDP bone scan in unfavorable risk prostate cancer patients.

Full Information

First Posted
February 17, 2023
Last Updated
July 31, 2023
Sponsor
NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom
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1. Study Identification

Unique Protocol Identification Number
NCT05847166
Brief Title
A Phase 2/3,PSMA-T4, Prostate Cancer
Official Title
A Phase 2/3, Open-Label Study, to Evaluate the Feasibility and Safety of Intravenous [99mTc]Tc-PSMA-T4 in Subjects With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this study are to evaluate the feasibility and safety of [99mTc]Tc-PSMA-T4 in the diagnosis and treatment planning of prostate cancer.
Detailed Description
This is a Phase 2/3, open-label study, with multicohort design that will enroll up to approximately 80 subjects with prostate cancer (40 for cohort A, 20 for cohorts B and C). Cohort A - lymph node assessment in intermediate risk group The patients will undergo [99mTc]Tc-PSMA-T4 semiWB- SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) with additional chest and abdominal CE computed tomography and [99mTc]Tc-MDP bone scan in unfavorable risk prostate cancer patients. Cohort B - general assessment (bone and lymph nodes) in high and very high-risk group The patients will undergo [99mTc]TcPSMA-T4 semi-WB- SPECT/CT and CE multiparametric MRI (according to PI-RADS 2.1 protocol), and chest and abdomen CE computed tomography, and skeletal scintigraphy ([99mTc]Tc-MDP bone scan). Cohort C - recurrent disease after definitive treatment (radiotherapy or surgery) The patients will undergo [99mTc]TcPSMA-T4 semiWB- SPECT/CT and the second confirmatory imaging modality or biopsy in the case of evidence on progressive disease (PSA persistence/recurrence or radiographic evidence of metastatic disease or clinical symptoms suggesting metastatic disease).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The expected duration of participation for each subject is approximately 17 weeks. This includes up to 1 week for screening, 4 weeks for diagnostic procedures, and 12 weeks for safety evaluation.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A - lymph node assessment in intermediate risk group
Arm Type
Active Comparator
Arm Description
The patients will undergo [99mTc]Tc-PSMA-T4 semiWB- SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) with additional chest and abdominal CE computed tomography and [99mTc]Tc-MDP bone scan in unfavorable risk prostate cancer patients
Arm Title
Cohort B - general assessment (bone and lymph nodes) in high and very high-risk group
Arm Type
Active Comparator
Arm Description
The patients will undergo [99mTc]TcPSMA-T4 semi-WB- SPECT/CT and CE multiparametric MRI (according to PI-RADS 2.1 protocol), and chest and abdomen CE computed tomography, and skeletal scintigraphy ([99mTc]Tc-MDP bone scan).
Arm Title
Cohort C - recurrent disease after definitive treatment (radiotherapy or surgery)
Arm Type
Active Comparator
Arm Description
The patients will undergo [99mTc]TcPSMA-T4 semiWB- SPECT/CT and the second confirmatory imaging modality or biopsy in the case of evidence on progressive disease (PSA persistence/recurrence or radiographic evidence of metastatic disease or clinical symptoms suggesting metastatic disease).
Intervention Type
Radiation
Intervention Name(s)
[99mTc]Tc-PSMA-T4
Intervention Description
[99mTc]Tc-PSMA-T4 for intravenous administration. The investigational medicinal product is to be prepared directly in a clinic by radiolabeling the radiopharmaceutical kit containing PSMA-T4 as a drug substance with sodium pertechnetate (99mTc) injection. The [99mTc]Tc-PSMA-T4 radiopharmaceutical should be used for targeted radionuclide SPECT imaging in patients with tumors and metastases of prostate cancer. The investigational medicinal product [99mTc]Tc-PSMA-T4 is dedicated for intravenous administration in radioactivity dose (555 - 740 MBq in cohorts A, B, C.
Primary Outcome Measure Information:
Title
Primary Endpoints
Description
Clinical feasibility in each cohort: the diagnostic method will be deemed a feasible approach if at least 80% of participants in each cohort fulfil the criteria of sensitivity (true positive) and specificity (true negative) of PSMA-T4 WB-SPECT/CT - detection all lesions that are pathologically or radiologically confirmed or suspicious in other modalities recommended in a particular clinical situation by international guidelines for prostate cancer diagnosis and treatment ("golden standards" separate for each cohort). Feasibility = (number of patients with true positive and/or true negative without false positive and/or false negative results of PSMA-T4 WB-SPECT/CT x 100%) / all patients. The patients will undergo PSMA-T4 semiWB-SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) withadditional chest and abdominal CE computed tomography and[ 99m Tc]Tc-MDP bone scan in unfavorable risk prostate cancer patients.
Time Frame
17 weeks
Secondary Outcome Measure Information:
Title
Secondary Outcome Measures
Description
Sensitivity(number of true positives x 100%)/(number of true positives + number of false negatives) Specificity:(number of true negatives x 100%)/(number of true negatives + number of false positives) Positive and negative predictive value: Positive predictive value defined as number of true positives x 100%/number of true positives + number of false positives. Negative predictive value defined as number of true negatives x 100%/number of true negatives + number of false negatives. The patients will undergo PSMA-T4 semiWB-SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) withadditional chest and abdominal CE computed tomography and[ 99m Tc]Tc-MDP bone scan in unfavorable risk prostate cancer patients.
Time Frame
17 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older. PS ECOG < 2 Prior diagnosis of any type of prostate cancer with a Gleason score (GlS) above 6. Confirmatory prostate biopsy, pelvic MRI and bone scan within 1 month before screening Willingness to participate in this study and to obtain written informed consent. Additional inclusion criteria for each cohort: Cohort A: Intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer Greater than 10% chance of lymph node involvement assessed using the Memorial Sloan Kettering nomogram for probability of lymph node involvement in prostate cancer patients. Cohort B: High or very high-risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer Cohort C: Biochemical failure after radical prostatectomy defined as failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after RP with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence) OR biochemical failure after definitive radiotherapy based on Phoenix Consensus OR radiographic evidence of metastatic disease without PSA persistence/recurrence OR clinical symptoms suggesting distant metastases. Exclusion Criteria: No histopathological confirmation of prostate cancer. Patients with pacemakers or metal parts that prevent pelvic MRI to confirm the presence of prostate cancer. Infection with hepatitis B virus (including carriers) during screening, i.e. hepatitis B positive surface antigen (HBsAg) or positive hepatitis C (anti-HCV) antibody. Infected with acquired immunodeficiency (HIV). Abnormal liver function including a significant increase of liver enzymes like: ALAT, ASPAT, alkaline phosphatase (AP) greater than 5x upper limit normal (ULN) and an increase in bilirubin greater than 2xULN. Renal impairment including GFR <30 ml / min. Within 6 months before inclusion into the study: myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.); Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia), second or higher degree atrio-ventricular (AV) heart block. Cerebrovascular accident, transient ischemic attack, acute stroke etc. Subjects with pulmonary embolism or deep vein thrombosis have been reported within the last 6 months. An active infection that the investigator considers precluding the patient from being included in the study, such as urinary tract infections, respiratory tract infections, and diabetes infection within the diabetic foot with osteomyelitis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Garnuszek, Sponsor
Phone
+48 22 273 1700
Email
Piotr.Garnuszek@polatom.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna Socko, CRO
Email
k.socko@genelytica.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Garnuszek, Sponsor
Organizational Affiliation
NCBJ Polatom
Official's Role
Study Director
Facility Information:
Facility Name
GAMMED Centrum Diagnostyczno-Lecznicze
City
Warszawa
State/Province
Lelechowska 5
ZIP/Postal Code
02-351
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GENELYTICA
Phone
513466270
Email
k.socko@genelytica.com
First Name & Middle Initial & Last Name & Degree
Jarosław Ćwikła, Prof.
Facility Name
Centrum Onkologii im. prof. F. Łukaszczyka
City
Bydgoszcz
State/Province
Ul. Dr Izabeli Romanowskiej 2
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GENELYTICA
Phone
513466270
Email
k.socko@genelytica.com
First Name & Middle Initial & Last Name & Degree
Bogdan Małkowski, Prof
First Name & Middle Initial & Last Name & Degree
Marta Maruszak-Parada, Dr
Facility Name
4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
City
Wrocław
State/Province
Weigla 5
ZIP/Postal Code
53-114
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GENELYTICA
Phone
513466270
Email
k.socko@genelytica.com
First Name & Middle Initial & Last Name & Degree
Andrzej Kołodziejczyk, Dr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Clinical Study Report (CSR)
IPD Sharing Time Frame
2024
IPD Sharing Access Criteria
After contact and approval of the Sponsor

Learn more about this trial

A Phase 2/3,PSMA-T4, Prostate Cancer

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