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Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
123-I-MIP-1072
123-I-MIP-1095
Sponsored by
Molecular Insight Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate cancer, Imaging

Eligibility Criteria

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

Inclusion Criteria:

  • Have a prior histological diagnosis of prostate cancer.

  • Have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI plus:

    1. PSA> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or
    2. PSA> 20 if intact prostate
  • Have platelet count of > 50,000/mm3
  • Have neutrophil count of > 1,000/mm3
  • Provide written informed consent and willing to comply with protocol requirements
  • Greater than or equal to 18 years of age
  • Can be on hormonal therapy if dose stable for > 90 days

Exclusion Criteria:

  • Karnofsky performance status of <60
  • Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
  • Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants).
  • Patient received external beam therapy or chemotherapy within the last 30 days
  • Administered a radioisotope within 5 physical half lives prior to study enrollment
  • Serum creatinine > 3.5 mg/dL
  • Total bilirubin > 2.5 times the upper limit of normal
  • Liver transaminases greater than 5x the upper limit of normal
  • 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
  • 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
  • Is determined by the Investigator that the patient is clinically unsuitable for the study
  • Have had any other malignancies within 5 years other than basal or squamous cell carcinoma of the skin.

Sites / Locations

  • Johns Hopkins Medical Institutes - Neuroradiology Division
  • New York Weill Cornell Medical Center - New York Presbyterian Hospital
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

123-I-MIP-1072 administration followed by 123-I-MIP-1095 administration two weeks later.

123-I-MIP-1095 administration followed by 123-I-MIP-1072 administration two weeks later.

Outcomes

Primary Outcome Measures

To examine the pharmacokinetics and organ radiation dosimetry of 123-I-MIP-1072 and 123I-MIP-1095 in patients with prior histological diagnosis of prostate cancer with evidence of recurrent metastatic disease.

Secondary Outcome Measures

To examine whole body excretion and metabolism of 123-I-MIP-1072 and 123-I-MIP-1095 in patients with recurrent metastatic prostate cancer.
To evaluate the safety of administering a 10.0 mCi dose of 123-I-MIP-1072 and 123-I-MIP-1095 to patients with recurrent metastatic prostate cancer.
Optimize imaging parameters

Full Information

First Posted
July 8, 2008
Last Updated
October 7, 2011
Sponsor
Molecular Insight Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00712829
Brief Title
Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents
Official Title
A Phase I Study Evaluating the Safety, Pharmacokinetics, Tissue Distribution, Metabolism of Small Molecule Inhibitors of Prostate Specific Membrane Antigen: Determination of I-123 Radiation Dosimetry for 123-I-MIP-1072 and 123-I-MIP-1095
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molecular Insight Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single blinded, randomized, cross-over design. Up to 12 patients will be randomly administered a single 10.0 mCi dose of 123I-MIP-1072 or 123I-MIP-1095 (study drugs). The second (alternate) study drug will be administered approximately 14 days after the first. A final follow-up visit will occur approximately 2 weeks after the injection of the alternate study drug.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
123-I-MIP-1072 administration followed by 123-I-MIP-1095 administration two weeks later.
Arm Title
2
Arm Type
Experimental
Arm Description
123-I-MIP-1095 administration followed by 123-I-MIP-1072 administration two weeks later.
Intervention Type
Drug
Intervention Name(s)
123-I-MIP-1072
Intervention Description
10 mCi intravenous injection given one time during the study
Intervention Type
Drug
Intervention Name(s)
123-I-MIP-1095
Intervention Description
10 mCi intravenous injection given one time during the study
Primary Outcome Measure Information:
Title
To examine the pharmacokinetics and organ radiation dosimetry of 123-I-MIP-1072 and 123I-MIP-1095 in patients with prior histological diagnosis of prostate cancer with evidence of recurrent metastatic disease.
Secondary Outcome Measure Information:
Title
To examine whole body excretion and metabolism of 123-I-MIP-1072 and 123-I-MIP-1095 in patients with recurrent metastatic prostate cancer.
Title
To evaluate the safety of administering a 10.0 mCi dose of 123-I-MIP-1072 and 123-I-MIP-1095 to patients with recurrent metastatic prostate cancer.
Title
Optimize imaging parameters

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a prior histological diagnosis of prostate cancer. Have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, CT scan or MRI plus: PSA> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or PSA> 20 if intact prostate Have platelet count of > 50,000/mm3 Have neutrophil count of > 1,000/mm3 Provide written informed consent and willing to comply with protocol requirements Greater than or equal to 18 years of age Can be on hormonal therapy if dose stable for > 90 days Exclusion Criteria: Karnofsky performance status of <60 Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively) Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants). Patient received external beam therapy or chemotherapy within the last 30 days Administered a radioisotope within 5 physical half lives prior to study enrollment Serum creatinine > 3.5 mg/dL Total bilirubin > 2.5 times the upper limit of normal Liver transaminases greater than 5x the upper limit of normal 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 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 Is determined by the Investigator that the patient is clinically unsuitable for the study Have had any other malignancies within 5 years other than basal or squamous cell carcinoma of the skin.
Facility Information:
Facility Name
Johns Hopkins Medical Institutes - Neuroradiology Division
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
New York Weill Cornell Medical Center - New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents

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