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

Molecular Insight Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: 123-I-MIP-1072; Drug: 123-I-MIP-1095

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712829

TX-P101

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: 123-I-MIP-1095

Drug: 123-I-MIP-1072

2

Experimental group

Description:

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

Treatment:

Drug: 123-I-MIP-1095

Drug: 123-I-MIP-1072