Prostate CancerPhase 1NCT00712829
Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents
A Phase 1 study testing 123-I-MIP-1072 and 123-I-MIP-1095 in people with Prostate Cancer, run by Molecular Insight Pharmaceuticals, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 123-I-MIP-1072 and 123-I-MIP-1095
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2008to Jan 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Medical Institutes - Neuroradiology Division
Baltimore, Maryland, 21287
Duke University Medical Center
Durham, North Carolina, 27710
New York Weill Cornell Medical Center - New York Presbyterian Hospital
New York, New York, 10021
About this study
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
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.
- Conditions
- Prostate Cancer
- Being tested
- 123-I-MIP-1072, 123-I-MIP-1095
- Keywords
- Prostate cancer, Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
123-I-MIP-1072Drug
10 mCi intravenous injection given one time during the study
123-I-MIP-1095Drug
10 mCi intravenous injection given one time during the study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 123-I-MIP-1072 administration followed by 123-I-MIP-1095 administration two weeks later. Receives: Drug: 123-I-MIP-1072; Drug: 123-I-MIP-1095 |
| 2 | Experimental | 123-I-MIP-1095 administration followed by 123-I-MIP-1072 administration two weeks later. Receives: Drug: 123-I-MIP-1072; Drug: 123-I-MIP-1095 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molecular Insight Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712829
- Sponsor's protocol ID
- TX-P101
- Status last verified
- Oct 2011
- First submitted
- 8 Jul 2008
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00712829
- Acronym / sponsor ID
- TX-P101
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Molecular Insight Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 123-I-MIP-1072, Drug: 123-I-MIP-1095123-I-MIP-1072 administration followed by 123-I-MIP-1095 administration two weeks later. |
| 2 | Experimental | Drug: 123-I-MIP-1072, Drug: 123-I-MIP-1095123-I-MIP-1095 administration followed by 123-I-MIP-1072 administration two weeks later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 123-I-MIP-107210 mCi intravenous injection given one time during the study | Drug | 1, 2 |
| 123-I-MIP-109510 mCi intravenous injection given one time during the study | Drug | 1, 2 |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 123-I-MIP-1072 and 123-I-MIP-1095 in people with Prostate Cancer, run by Molecular Insight Pharmaceuticals, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.