Clinical trial · Interventional
Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
A Randomized, Open-Label, Phase 2 Trial Examining the Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men With Non-metastatic Prostate Cancer and a Rising Serum Prostate Specific Antigen After Primary Therapy
NCT01431391CI-TRIAL-00027870completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.
Conditions
Conditions (3)
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 |
| Prostatic Adenocarcinoma | — | UNRESOLVED | — |
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| leuprolide acetate | Drug | Leuprolide | ALIAS |
| sipuleucel-T | Biological | Autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Sipuleucel-T followed by ADT
- description
- Arm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
- interventionNames
- Biological: sipuleucel-T
- Drug: leuprolide acetate
- type
- EXPERIMENTAL
- label
- Arm 2: ADT followed by sipuleucel-T
- description
- Arm 2: Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Hormone-sensitive prostate cancer * Non-metastatic disease, as evidenced by negative bone scan or computed tomography of the abdomen and pelvis * ECOG performance status ≤ 1 * Histologically documented prostate cancer * Prior primary therapy for prostate cancer * Rising PSA with a PSADT of ≤ 12 months * Testosterone ≥ 200 ng/dL ≤ 28 days of registration * Adequate hematologic, renal, and liver function * Must live in a permanent residence within a comfortable driving distance (round-trip within one day) to the clinical research site Exclusion Criteria: * Requires systemic ongoing immunosuppressive therapy * History of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF * Prior sipuleucel-T therapy * Prior ADT therapy ≤ 6 months prior to registration or ≥ 6 months duration in total * If subject has a history of any other stage III/IV malignancy, the subject must be disease free and off any malignancy-related treatment for at least 10 years. If the subject has a history of any stage I-II malignancy, the subject must be disease free and off any malignancy-related treatment for at least 5 years. * Prior experimental immunotherapy or on an experimental clinical trial within 1 year * Received denosumab or XRT ≤ 6 months prior to registration * Received chemotherapy or GM-CSF ≤ 90 days prior to registration * Received any of the following medications or interventions ≤ 28 days prior to registration * major surgery requiring general anesthesia * systemic immunosuppressive therapy * other prescription treatment for prostate cancer * Active infection within 1 week of registration * Likely to receive XRT or surgery for prostate cancer during the study period * Any medical intervention, any other condition, or any circumstances that could compromise the study.
References
Publications (0)
Data not yet available
No reference posted for this study.