Clinical trial · Interventional
A Study of Positron Emission Tomography (PET) With [89]Zr-Df-IAb2M in Patients With High-risk Prostate Cancer
A Phase 2 Study of Positron Emission Tomography (PET) With [89]Zr-Df-IAb2M in Patients With High-risk Prostate Cancer
NCT02424513CI-TRIAL-00018107withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Clinical trial was postponed as a result of restructured business priorities.
Summary
Brief summary (as posted)
This is a prospective, multicenter, open-label, non-randomized study evaluating the ability of \[89\]Zr-Df-IAb2M to detect local, regional and metastatic prostate cancer confirmed by pathology.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [89Zr]Df-IAB2M | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [89Zr]Df-IAB2M
- description
- A single intravenous infusion of 2.5 mCi of \[89Zr\]Df-IAB2M in a mass dose of 10 mg.
- interventionNames
- Radiation: [89Zr]Df-IAB2M
Primary outcomes (5)
- measure
- Sensitivity of [89]Zr-Df-IAb2M PET/CT for the detection of extraprostatic sites of prostate cancer as confirmed by biopsy and/or surgically resected tissue.
- timeFrame
- 6 weeks
- measure
- Specificity of [89]Zr-Df-IAb2M PET/CT for the detection of extraprostatic sites of prostate cancer as confirmed by biopsy and/or surgically resected tissue.
- timeFrame
- 6 weeks
- measure
- Positive Predicted Value of [89]Zr-Df-IAb2M PET/CT for the detection of extraprostatic sites of prostate cancer as confirmed by biopsy and/or surgically resected tissue.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological diagnosis of prostate adenocarcinoma. 2. Patients considered candidates for radical prostatectomy and pelvic lymph node dissection. These patients may or may not have identified nodal metastasis on conventional imaging but would still be candidates for radical prostatectomy and pelvic lymph node dissection. 3. Patients, who are at high-risk for pelvic lymph node metastasis as defined by a lymph node involvement risk of greater than or equal to 20% using the Briganti nomogram. 4. Age ≥ 18 years. 5. Ability to understand and willingness to sign IRB approved consent form 6. For men of child-producing potential, the use of effective contraceptive methods during the study. Exclusion Criteria: 1. Treatment or plans for treatment with radiation therapy, surgery, chemotherapy, or investigational therapy between the time of conventional imaging, \[89\]Zr-Df-IAB2M PET/CT and the surgical resection or biopsy procedures used for the study evaluation. 2. Unwillingness or inability to comply with procedures required in this protocol. 3. Other cancers that might potentially interfere with the reading and interpretation of \[89\]Zr-Df-IAB2M PET/CT scans. 4. Patients who are currently receiving any other investigational agent. 5. Patients who have had or are currently receiving androgen deprivation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.