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NCT Number: NCT01774071

Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer

The purpose of this study is to see if a new diagnostic research agent named 89Zr-DFO-MSTP2109A can show prostate cancer tumors on a PET scan; as well as see how long 89Zr-DFO-MSTP2109A lasts in the blood when given in small amounts. DFO-MSTP2109A is an antibody that works against STEAP1 - found on the surface of prostate cancer cells. Attached to the DFO-MSTP2109A is a radioactive material called 89ZR, which allows it to be imaged by a PET scanner. The results of this study may help researchers know whether 89Zr-DFO-MSTP2109A can be used as a diagnostic agent for finding prostate cancer that have STEAP1 on its surface with a PET scanner. The reason why identifying STEAP1 on prostate cancer cells is that new therapies are being developed to target STEAP1 prostate cancer cells.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To be included in this study, patients should be eligible for enrollment into protocol 11-016 (therapy with the DSTP3086S ADC) or meet all of the following criteria:
  • Patients meeting the criteria for enrollment on research protocol 11-016 to receive DSTP3086S ADC (therapeutic ADC based on MSTP2109A) will be the preferred patients for this study. Patients that are to receive DSTP3086S will not be injected with DSTP2086S until imaging with 89Zr-DFOMSTP2109A is finished, approximately 1 week.
  • Adult male > 21years of age
  • Visible lesions by either CT, bone scan or MRI consistent with metastatic disease
  • Metastatic progressive disease
  • Imaging modalities:
  • Bone scan: new osseous lesion and/or MRI or CT: An increase in measurable soft tissue disease or the appearance of new sites of disease.

Or

  • PSA changes over range of value 26%
  • Patients with histologically confirmed prostate cancer at MSKCC
  • STEAP1 antigen positive tissue known from prior IHC testing or if STEAP1 status is not known archival sample will be sent to Genentech for IHC. Samples need to be positive, when feasible metastatic lesions will be tested preferentially rather than the primary.
  • Performance status of 60 or higher (Karnofsky scale) (Appendix A)
  • Ability to understand and willingness to sign a written informed consent document
  • PSA levels to be taken within 2 weeks of antibody administration.

Exclusion criteria

  • Patients meeting any of the following exclusion criteria will not be eligible for study entry:
  • Previous anaphylactic reaction to human, humanized or chimeric antibody
  • Hematologic
  • Platelets <75K/mcL
  • ANC <1.0 K/mcL
  • Hepatic laboratory values
  • AST/ALT >2.5 x ULN
  • Renal laboratory values
  • Bilirubin >1.5 x ULN (institutional upper limits of normal)
  • eGFR < 30mL/min/1.73m2
  • Patients with history of hypersensitivity reaction to any component of 89Zr-DFOMSTP2109A, including DFO

Treatment and study plan

89Zr- DFO-MSTP2109A

Drug

If you are enrolled onto Group 1:

Once you are given the diagnostic agent, the following procedures will be done:

PET scans at the approximate times:

  • 1-4 hours after the injection
  • 24 hours after the injection (the next day, Day 2)
  • 48-120 hours after the injection (on either Day 3, 4, or 5)
  • 144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days,
  • Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection.
  • At each time of your scheduled PET scan.

89Zr DFO-MSTP2109A

Drug

If you are enrolled onto Group 2:

Once you are given the study drug, the following procedures will be done:

You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (~ 3-7 days after injection).

No research blood work will be drawn in Group 2

Primary outcomes

  1. Percentage of Participants With Histologically Positive Lesions That Are Positive on Imaging

    Time frame: 2 years

    Antibody imaging will be considered feasible if 75% of the patients are antibody-imaging-positive. We will enroll 6 patients (cohort 1A) at the 10mg dose level for an initial decision on feasibility. If 4 or more of these patients have 20% or more of their active lesions detectable by 89Zr-DFO-MSTP2109A then we will consider the agent feasible for imaging, otherwise we will proceed to cohort 1B. If the true feasibility rate is 40%, this rule will affords more than 82% chance that cohort 1B will be opened for enrollment; this probability is less than 17% if the true feasibility is 75%.

  2. Number of Participants Evaluated for AEs

    Time frame: 2 years

    All participants will be evaluated for adverse events which will be graded for intensity on a scale of 0 to 5. Severity grades will be recorded and based on the CTCAE v4.0. Adverse events will be defined graded using CTCAE V4.0.

  3. Rate of Clearance of Tracer 89Zr-DFO-MSTP2109A

    Time frame: up to 168 hours

    Serial blood draws will be used to estimate the pharmacokinetic profile of the 10mg 89Zr-DFO-MSTP2109A in this patient population. Blood samples will be obtained in green top tube: Just prior to injection of 89Zr-DFO-MSTP2109A (baseline)Approximately 5 ± 2, 15 ± 5, 30 ± 9, 60 ± 19, and 120 to 240 minutes after injection of the tracer. One sample at the time of each subsequent day of imaging (24 + 8h, ~48-96h and ~120-168h post injection).

  4. Biodistribution/SUVmax

    Time frame: 2 years

    A PET-CT scan extending from top of skull to mid thighs will be performed to determine the biodistribution/SUVmax in bone and soft tissue

Secondary outcomes

  1. Percentage of Histologically Positive Lesions That Were True Positive on PET Imaging

    Time frame: 2 years

    Ability of 89Zr-DFO-MSTP2109A PET to detect sites of metastatic prostate cancer.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

A Phase I/II Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2013
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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