Prostate Cancer
Conditions
Keywords
Metastatic Prostate Adenocarcinoma
Brief summary
This is a single-blind, randomized, cross-over design. Patients with metastatic prostate adenocarcinoma; newly diagnosed, high-risk patients with prostate adenocarcinoma; and healthy subjects will be administered a single intravenous dose of each of the study drugs 99mTc MIP 1404 and 99mTc MIP 1405 administered approximately 14 to 21 days apart.
Detailed description
This trial is a single-blind, randomized, cross-over design. Up to six patients with confirmed metastatic prostate adenocarcinoma; six newly diagnosed, high-risk patients with prostate adenocarcinoma; and up to six healthy volunteers will receive 20.0 (± 3) mCi of intravenously administered 99mTc MIP 1404 or 99mTc MIP 1405. Whole-body planar scintigraphic images will be acquired at various times post-injection over 24 hours. A pelvic SPECT/CT image will be acquired on the first day. Blood and urine will be collected for pharmacokinetic measurements and metabolic analysis over 24 hours. Each patient will receive an initial study drug administration and a second study drug administration approximately 14 to 21 days after the first. A final follow-up visit will occur approximately 2-3 weeks after the second study drug.
Interventions
RADIATION99mTc MIP 1404
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1404
RADIATION99mTc MIP 1405
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405
Sponsors
Molecular Insight Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the following criteria to be enrolled in this study. 1. Male aged 21 years or older. 2. Ability to provide signed informed consent and willingness to comply with protocol requirements. 3. Participants must agree to use condoms for a period of seven days after each injection, if engaged in sexual activity. Additional Inclusion Criteria for Patients: i. Histologic diagnosis of prostate cancer by validated medical history. (Pathology report, if available). ii. Evidence of metastatic disease demonstrated by a documented abnormal bone scan, CT scan, or MRI plus a Clinical Stage 3 and Gleason Score ≥ 8. iii. Karnofsky performance is ≥ 60. Additional Inclusion Criteria for Healthy Volunteers: i. PSA laboratory assessment within normal range (PSA \< 4 ng/ml). ii. Normal findings on a digital rectal examination. iii. Hemoglobin and hematocrit within normal range.
Exclusion criteria
Participants must NOT meet any of the following criteria to be enrolled in this study. 1. Received an investigational compound and/or medical device or is part of an investigational study within the past 30 days before enrollment into this study. 2. Subject was administered a radioisotope within 5 physical half lives of that radioisotope prior to study enrollment 3. Have any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations. 4. Participant is determined by the Investigator to be clinically unsuitable for the study. 5. Serum creatinine ≥ 2.0 mg/dl 6. Total bilirubin ≥ 2.0 mg/dl 7. Liver transaminases ≥ 1.5 x ULN 8. Platelet count \< 150,000/mm3 9. Absolute neutrophil count (ANC) \< 2,000/mm3. 10. Hematocrit \< 30% or hemoglobin \< 10 g/dl. 11. Abnormal coagulation profile (PT, PTT or INR) \> 1.3 ULN unless on therapeutic anticoagulation. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Administered dose | From the time of signed ICF through 2 weeks post injection of the second study drug administration (up to 8 weeks total for each subject) | The safety data will be summarized for all patients receiving at least one dose of study drug. Summary tables, including change from pre dose to post dose where applicable, will be presented for the following safety endpoints: * Treatment emergent adverse events * Clinical Laboratory Evaluations * Physical examination, vital signs, and ECGs |
| Pharmacokinetics of Administered Dose | From the time of signed ICF through 2 weeks post injection of the second study drug administration (up to 8 weeks total for each subject) | Standard PK parameters of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be calculated, including but not limited to: clearance, distribution half-life, elimination half-life, mean residence time and maximum concentration. These PK parameters will be listed by subject and summarized. Blood clearance and urinary recovery over time will be displayed in figures. Urine metabolites and impurities of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be listed by subject and summarized. The PK population will be used in the analysis of pharmacokinetics and metabolism. |
| Biodistribution of Administered Dose | : From the time of signed ICF through 2 weeks post injection of the second study drug administration (up to 8 weeks total for each subject) | Percent of injected activity (%IA) in a set of source organs will be determined by comparing a reference whole body scan to subsequent whole body scans to determine percentage of administered activity for source organs at the various scanning times. This biodistribution data will then be used to mathematically model source organ residence times, which will be used to estimate radiation absorbed dose to target organs. Percent injected activity and estimated residence times will be summarized by organ. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Excretion of administered dose | From the time of signed ICF through 2 weeks post injection of the second study drug administration (up to 8 weeks total for each subject) | Standard PK parameters of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be calculated, including but not limited to: clearance, distribution half-life, elimination half-life, mean residence time and maximum concentration. These PK parameters will be listed by subject and summarized. Blood clearance and urinary recovery over time will be displayed in figures. Urine metabolites and impurities of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be listed by subject and summarized. The PK population will be used in the analysis of pharmacokinetics and metabolism. |
| Dosimetry of administered dose | From the time of signed ICF through 2 weeks post injection of the second study drug administration (up to 8 weeks total for each subject) | To calculate the estimated radiation dosimetry to normal organs based on the pharmacokinetic and normal tissue distribution in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers |
| Metabolism of administered dose | From the time of signed ICF through 2 weeks post injection of the second study drug administration (up to 8 weeks total for each subject) | Standard PK parameters of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be calculated, including but not limited to: clearance, distribution half-life, elimination half-life, mean residence time and maximum concentration. These PK parameters will be listed by subject and summarized. Blood clearance and urinary recovery over time will be displayed in figures. Urine metabolites and impurities of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be listed by subject and summarized. The PK population will be used in the analysis of pharmacokinetics and metabolism. |
Countries
United States
Outcome results
None listed