Trial · Interventional

CompletedPhase 2Results postedRegistry data

Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer

NCTNCT01431391Other idP10-2

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 68 participants (actual)
Sponsor: Dendreon · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Sept 2011
Primary completion: Dec 2014
Completion: Dec 2014
First posted: 9 Sept 2011 (estimated)
Last update posted: 30 May 2017
Conditions: Prostatic Neoplasm · Prostate Cancer · Prostatic Adenocarcinoma

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20112012201320142015

Ph 2
Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
NCT01431391
Sept 2011 to Dec 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown 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.

Interventions

sipuleucel-TBiological
leuprolide acetateDrug

Arms2

Experimental
Arm 1: Sipuleucel-T followed by ADT
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.
Experimental
Arm 2: ADT followed by sipuleucel-T
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024
Time frame · PA2024 ELISPOT counts at Month 24
Registry description
Immune response at month 24 as evaluated by IFN-γ ELISPOT specific for PA2024 following sipuleucel-T/ADT treatment regimens to determine if order of administration impacted immune response.

Secondary outcomes(1)

Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024
Time frame · Month 24
Registry description
A participant was considered to have an immune response it the post-baseline PA2024-specific IFN-g ELISPOT count was \>18

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· PA2024 ELISPOT counts at Month 24

Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024

Group	Value (IFN-γ ELISPOT (per 300,000 PBMC))	Spread
Arm 1: Sipuleucel-T Followed by ADT	81.0	28.0
Arm 2: ADT Followed by Sipuleucel-T	61.1	23.7

Secondary and other outcome results(1)

Secondary outcomeNumber· Month 24

Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024

Group	Value (percentage of participants)
Arm 1:Sipuleucel-T Followed by ADT	88
Arm 2: ADT Followed by Sipuleucel-T	85

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Arm 1: Sipuleucel-T Followed by ADTSubjects 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.	–	1 / 34	33 / 34
Arm 2: ADT Followed by Sipuleucel-TSubjects 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.	–	5 / 34	34 / 34

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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