Prostate CancerPhase 1NCT01572701

Pilot Study of 99mTc-MIP-1404 SPECT/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection

A Phase 1 study testing 99mTc-MIP-1404 in people with Prostate Cancer, run by Molecular Insight Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: 99mTc-MIP-1404
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Jan 2012to Jun 2012
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 21 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Male aged 21 years or older.
Ability to provide signed informed consent and willingness to comply with protocol requirements.
Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
Participant is deemed to be high-risk with potential for pelvic lymph node involvement. The criteria for high-risk are:
Patient has PSA value >10 and clinical stage T2 or higher, and Gleason score 8, 9 or 10.
Patient has PSA value >20 and clinical stage T2 or higher, and Gleason score

Show all 10Show fewer

Participant is or will be scheduled to undergo standard of care prostatectomy and/or pelvic lymph node dissection.
Have had (within previous 2 months) or will undergo diagnostic CT or MRI imaging prior to surgery.
Have had (within previous 2 months) or will undergo bone scan imaging prior to surgery.
Participants must agree to use an acceptable form of birth control throughout the study period. Participants must use condoms for a period of seven days after each injection, if engaged in sexual activity.

Who cannot join

Participants for whom participating would significantly delay the scheduled standard of care therapy.
Participants administered a radioisotope within 5 physical half lives prior to study enrollment.
Participants with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Weill Cornell Medical College
New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase 1 Pilot Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection (PLND)

This is a single arm, open label study of up to 24 high risk prostate cancer patients scheduled for prostatectomy and/or pelvic lymph node dissection. Patients receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by SPECT/CT scan 3-6 hours after injection. As standard of care, patients will undergo prostatectomy and/or pelvic lymph node dissection (PLND) within two weeks of study drug dosing. Patients may receive a second injection of study drug within 24 hours of surgery to measure activity counts in tissue samples post-surgery, but prior to pathology processing. 99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

Conditions: Prostate Cancer
Being tested: 99mTc-MIP-1404
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

99mTc-MIP-1404Drug
20 (±3) mCi of study drug will be administered by IV injection as a slow bolus and flushed with approximately 10 mL of saline

Study groups in NCT01572701
Study group	Role	What they receive
20 (±3) mCi of study drug	Experimental	Not described Receives: Drug: 99mTc-MIP-1404

What is being measured

The primary outcome is the main question the study is designed to answer.

Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404
99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
Measured: Post-procedure

Secondary outcomes (3)

Safety of 99mTc-MIP-1404: Change in Vital Signs from Pre-Dose to Post-Dose
Summary tables will present change from pre-dose to post-dose vital signs measurements.
Measured: Vital signs measurements will be measured, an expected average of 30 minutes before and after study drug injection
Intensity of 99mTc-MIP-1404 Uptake with Respect to PSMA expression
99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.
Measured: Post-procedure
Safety of 99mTc-MIP-1404: Summary of Treatment-Emergent Adverse Events (TEAEs)
TEAEs will be summarized by the Medical Dictionary for Regulatory Activities (MedDRA) body system and preferred term, by intensity, and by causal relationship to study agent.
Measured: Adverse events will be assessed for the duration of the study participation, an expected average of 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jun 2012

First posted6 Apr 2012 (estimated)
Study startJan 2012
Primary completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01572701
Sponsor's protocol ID: MIP-TcTx-P104
Status last verified: Nov 2015
First submitted: 5 Dec 2011
Last updated: 25 Nov 2015
Results posted: No
Data monitoring committee: No

Publications

Jung JA, Coakley FV, Vigneron DB, Swanson MG, Qayyum A, Weinberg V, Jones KD, Carroll PR, Kurhanewicz J. Prostate depiction at endorectal MR spectroscopic imaging: investigation of a standardized evaluation system. Radiology. 2004 Dec;233(3):701-8. doi: 10.1148/radiol.2333030672.
PubMed 15564406
Swindle P, Eastham JA, Ohori M, Kattan MW, Wheeler T, Maru N, Slawin K, Scardino PT. Do margins matter? The prognostic significance of positive surgical margins in radical prostatectomy specimens. J Urol. 2008 May;179(5 Suppl):S47-51. doi: 10.1016/j.juro.2008.03.137.
PubMed 18405751
Hocht S, Wiegel T, Bottke D, Jentsch H, Sternemann M, Rosenthal P, Hinkelbein W. Computed tomogram prior to prostatectomy. Advantage in defining planning target volumes for postoperative adjuvant radiotherapy in patients with stage C prostate cancer? Strahlenther Onkol. 2002 Mar;178(3):134-8. doi: 10.1007/s00066-002-0896-9.
PubMed 11962189
Kotzerke J, Prang J, Neumaier B, Volkmer B, Guhlmann A, Kleinschmidt K, Hautmann R, Reske SN. Experience with carbon-11 choline positron emission tomography in prostate carcinoma. Eur J Nucl Med. 2000 Sep;27(9):1415-9. doi: 10.1007/s002590000309.
PubMed 11007527
Pinto JT, Suffoletto BP, Berzin TM, Qiao CH, Lin S, Tong WP, May F, Mukherjee B, Heston WD. Prostate-specific membrane antigen: a novel folate hydrolase in human prostatic carcinoma cells. Clin Cancer Res. 1996 Sep;2(9):1445-51.
PubMed 9816319
Smith-Jones PM, Vallabahajosula S, Goldsmith SJ, Navarro V, Hunter CJ, Bastidas D, Bander NH. In vitro characterization of radiolabeled monoclonal antibodies specific for the extracellular domain of prostate-specific membrane antigen. Cancer Res. 2000 Sep 15;60(18):5237-43.
PubMed 11016653
Ghosh A, Heston WD. Tumor target prostate specific membrane antigen (PSMA) and its regulation in prostate cancer. J Cell Biochem. 2004 Feb 15;91(3):528-39. doi: 10.1002/jcb.10661.
PubMed 14755683
Kinoshita Y, Kuratsukuri K, Landas S, Imaida K, Rovito PM Jr, Wang CY, Haas GP. Expression of prostate-specific membrane antigen in normal and malignant human tissues. World J Surg. 2006 Apr;30(4):628-36. doi: 10.1007/s00268-005-0544-5.
PubMed 16555021
Milowsky MI, Nanus DM, Kostakoglu L, Sheehan CE, Vallabhajosula S, Goldsmith SJ, Ross JS, Bander NH. Vascular targeted therapy with anti-prostate-specific membrane antigen monoclonal antibody J591 in advanced solid tumors. J Clin Oncol. 2007 Feb 10;25(5):540-7. doi: 10.1200/JCO.2006.07.8097.
PubMed 17290063
Hillier SM, Maresca KP, Femia FJ, Marquis JC, Foss CA, Nguyen N, Zimmerman CN, Barrett JA, Eckelman WC, Pomper MG, Joyal JL, Babich JW. Preclinical evaluation of novel glutamate-urea-lysine analogues that target prostate-specific membrane antigen as molecular imaging pharmaceuticals for prostate cancer. Cancer Res. 2009 Sep 1;69(17):6932-40. doi: 10.1158/0008-5472.CAN-09-1682. Epub 2009 Aug 25.
PubMed 19706750
Olson WC, Heston WD, Rajasekaran AK. Clinical trials of cancer therapies targeting prostate-specific membrane antigen. Rev Recent Clin Trials. 2007 Sep;2(3):182-90. doi: 10.2174/157488707781662724.
PubMed 18474004
Rajasekaran AK, Anilkumar G, Christiansen JJ. Is prostate-specific membrane antigen a multifunctional protein? Am J Physiol Cell Physiol. 2005 May;288(5):C975-81. doi: 10.1152/ajpcell.00506.2004.
PubMed 15840561
Slovin SF. Targeting novel antigens for prostate cancer treatment: focus on prostate-specific membrane antigen. Expert Opin Ther Targets. 2005 Jun;9(3):561-70. doi: 10.1517/14728222.9.3.561.
PubMed 15948673

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Pilot Study of 99mTc-MIP-1404 Single Photon Emission Computed Tomography (SPECT)/CT Imaging in Men With Prostate Cancer Undergoing Prostatectomy and/or Pelvic Lymph Node Dissection (PLND)
ClinicalTrials.gov ID: NCT01572701
Acronym / sponsor ID: MIP-TcTx-P104
Conditions: Prostate Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Molecular Insight Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Jun 2012 (actual)
First posted: 6 Apr 2012 (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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
20 (±3) mCi of study drug	Experimental	Drug: 99mTc-MIP-1404

Who may qualify

Ages: 21 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male aged 21 years or older.
Ability to provide signed informed consent and willingness to comply with protocol requirements.
Past biopsy indicating the presence of adenocarcinoma of the prostate gland.
Participant is deemed to be high-risk with potential for pelvic lymph node involvement. The criteria for high-risk are:
Participant is or will be scheduled to undergo standard of care prostatectomy and/or pelvic lymph node dissection.

Key exclusion criteria (3 listed)

Participants for whom participating would significantly delay the scheduled standard of care therapy.
Participants administered a radioisotope within 5 physical half lives prior to study enrollment.
Participants with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.

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
99mTc-MIP-140420 (±3) mCi of study drug will be administered by IV injection as a slow bolus and flushed with approximately 10 mL of saline	Drug	20 (±3) mCi of study drug

Primary outcome

Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404
Time frame: Post-procedure
99mTc-MIP-1404 image data will be evaluated for visible uptake and compared with histopathology.

3 secondary outcomes

Safety of 99mTc-MIP-1404: Change in Vital Signs from Pre-Dose to Post-Dose
Time frame: Vital signs measurements will be measured, an expected average of 30 minutes before and after study drug injection
Intensity of 99mTc-MIP-1404 Uptake with Respect to PSMA expression
Time frame: Post-procedure
Safety of 99mTc-MIP-1404: Summary of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Adverse events will be assessed for the duration of the study participation, an expected average of 3 weeks

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 25 Nov 2015.
Background: PubMed 15564406Jung JA, Coakley FV, Vigneron DB, Swanson MG, Qayyum A, Weinberg V, Jones KD, Carroll PR, Kurhanewicz J. Prostate depiction at endorectal MR spectroscopic imaging: investigation of a standardized evaluation system. Radiology. 2004 Dec;233(3):701-8. doi: 10.1148/radiol.2333030672.
Background: PubMed 18405751Swindle P, Eastham JA, Ohori M, Kattan MW, Wheeler T, Maru N, Slawin K, Scardino PT. Do margins matter? The prognostic significance of positive surgical margins in radical prostatectomy specimens. J Urol. 2008 May;179(5 Suppl):S47-51. doi: 10.1016/j.juro.2008.03.137.
Background: PubMed 11962189Hocht S, Wiegel T, Bottke D, Jentsch H, Sternemann M, Rosenthal P, Hinkelbein W. Computed tomogram prior to prostatectomy. Advantage in defining planning target volumes for postoperative adjuvant radiotherapy in patients with stage C prostate cancer? Strahlenther Onkol. 2002 Mar;178(3):134-8. doi: 10.1007/s00066-002-0896-9.
Background: PubMed 11007527Kotzerke J, Prang J, Neumaier B, Volkmer B, Guhlmann A, Kleinschmidt K, Hautmann R, Reske SN. Experience with carbon-11 choline positron emission tomography in prostate carcinoma. Eur J Nucl Med. 2000 Sep;27(9):1415-9. doi: 10.1007/s002590000309.
Background: PubMed 9816319Pinto JT, Suffoletto BP, Berzin TM, Qiao CH, Lin S, Tong WP, May F, Mukherjee B, Heston WD. Prostate-specific membrane antigen: a novel folate hydrolase in human prostatic carcinoma cells. Clin Cancer Res. 1996 Sep;2(9):1445-51.
Background: PubMed 11016653Smith-Jones PM, Vallabahajosula S, Goldsmith SJ, Navarro V, Hunter CJ, Bastidas D, Bander NH. In vitro characterization of radiolabeled monoclonal antibodies specific for the extracellular domain of prostate-specific membrane antigen. Cancer Res. 2000 Sep 15;60(18):5237-43.
Background: PubMed 14755683Ghosh A, Heston WD. Tumor target prostate specific membrane antigen (PSMA) and its regulation in prostate cancer. J Cell Biochem. 2004 Feb 15;91(3):528-39. doi: 10.1002/jcb.10661.
Background: PubMed 16555021Kinoshita Y, Kuratsukuri K, Landas S, Imaida K, Rovito PM Jr, Wang CY, Haas GP. Expression of prostate-specific membrane antigen in normal and malignant human tissues. World J Surg. 2006 Apr;30(4):628-36. doi: 10.1007/s00268-005-0544-5.
Background: PubMed 17290063Milowsky MI, Nanus DM, Kostakoglu L, Sheehan CE, Vallabhajosula S, Goldsmith SJ, Ross JS, Bander NH. Vascular targeted therapy with anti-prostate-specific membrane antigen monoclonal antibody J591 in advanced solid tumors. J Clin Oncol. 2007 Feb 10;25(5):540-7. doi: 10.1200/JCO.2006.07.8097.
Background: PubMed 19706750Hillier SM, Maresca KP, Femia FJ, Marquis JC, Foss CA, Nguyen N, Zimmerman CN, Barrett JA, Eckelman WC, Pomper MG, Joyal JL, Babich JW. Preclinical evaluation of novel glutamate-urea-lysine analogues that target prostate-specific membrane antigen as molecular imaging pharmaceuticals for prostate cancer. Cancer Res. 2009 Sep 1;69(17):6932-40. doi: 10.1158/0008-5472.CAN-09-1682. Epub 2009 Aug 25.
Background: PubMed 18474004Olson WC, Heston WD, Rajasekaran AK. Clinical trials of cancer therapies targeting prostate-specific membrane antigen. Rev Recent Clin Trials. 2007 Sep;2(3):182-90. doi: 10.2174/157488707781662724.
Background: PubMed 15840561Rajasekaran AK, Anilkumar G, Christiansen JJ. Is prostate-specific membrane antigen a multifunctional protein? Am J Physiol Cell Physiol. 2005 May;288(5):C975-81. doi: 10.1152/ajpcell.00506.2004.

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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.

Douglas S Scherr, MD principal investigator

New York Presbyterian Hospital - Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 99mTc-MIP-1404 in people with Prostate Cancer, run by Molecular Insight Pharmaceuticals, Inc. at 1 site 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 10 inclusion and 3 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 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Tissue distribution of 20 (± 3) mCi 99mTc-MIP-1404 (time frame: Post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01572701, which also lists 13 linked publications.

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 25 Nov 2015.