Clinical trial · Interventional
PET/MR Assessment of Sipuleucel T Treatment for Metastatic Castration Resistant Prostate Cancer
Multimodality Imaging Assessment of Sipuleucel T Treatment and in Vivo Immune Response of Metastatic Castration Resistant Prostate Cancer Patients
NCT02042053CI-TRIAL-00028659terminatedN/AClinicalTrials.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): Due to PI leaving the institution
Summary
Brief summary (as posted)
This study intents to provide an initial evaluation of the utility of positron emission tomography and magnetic resonance (PET/MR) imaging measures for the prediction of immunological response to Sipuleucel T (SipT) therapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/CT | Device | — | UNRESOLVED |
| PET/MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET/MR
- description
- Patients treated with SipT (standard of care) undergo FDG-PET/MRI, NaF-PET/CT and blood drawing at 3 time points: baseline, Day 7 after the last SipT infusion, Week 10 after the last SipT infusion.
- interventionNames
- Device: PET/CT
- Device: PET/MRI
Primary outcomes (1)
- measure
- Percentage of patients with imaging parameter change(s) among the patients with immunological response
- timeFrame
- up to 14 weeks
- description
- NaF-PET/CT, FDG-PET/MRI, and blood drawing (for immunological response) are performed on patients at baseline, day 7 after the last SipT infusion, and week 10 after the last SipT infusion. The changes in SUV (standard uptake value) max on FDG-PET and NaF-PET, in MRI-ADC (apparent diffusion coefficient ) value, in MRI contrast enhancement, and in T2 lesion size will be measured.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men ≥ 18 years of age * History of prostate cancer treated with androgen deprivation * Serum Testosterone levels \<50 ng/mL * Established asymptomatic or minimally symptomatic metastasis * Eastern Cooperative Oncology Group (ECOG) performance status≤2 * Accept the terms of the imaging modalities and performance at pre-established time points as described in the protocol and consent * Accept the terms for immune-monitoring blood drawing and performance at pre-established time points as described in the protocol and consent * Patients that are on steroids (prednisone up to 10mg daily or hydrocortisone 20 mg daily) alone or in combination with Zytega or ketoconazole prior to enrollment are eligible * Patients that are on steroids for an underlying chronic condition are eligible. (prednisone up to 10 mg daily, dexamethasone \<2 mg daily or fludrocortisone 0.1 mg daily orally) Exclusion Criteria: * Chemotherapy or radiation therapy treatment within 21 days of Sipuleucel-T * ECOG performance status \>2 * Prior treatment with Sipuleucel-T * Patients with a history of another primary malignancy within the last 2 years that was not curatively treated, excluding basal or squamous cell carcinoma of the skin * Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required * Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent * Active spinal cord compression.
References
Publications (0)
Data not yet available
No reference posted for this study.