Trial Outcomes & Findings for Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer (NCT NCT01431391)

Last Updated: 2017-05-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

68 participants

Primary outcome timeframe

PA2024 ELISPOT counts at Month 24

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1:Sipuleucel-T Followed by ADT 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 androgen deprivation therapy (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.	Arm 2: ADT Followed by Sipuleucel-T 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.
Overall Study STARTED	34	34
Overall Study Received ≥1 Leaukapheresis	34	34
Overall Study COMPLETED	26	30
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Sipuleucel-T Followed by ADT n=34 Participants 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.	Arm 2: ADT Followed by Sipuleucel-T n=34 Participants 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.	Total n=68 Participants Total of all reporting groups
Age, Continuous	65.4 years STANDARD_DEVIATION 1.4 • n=5 Participants	66.2 years STANDARD_DEVIATION 1.1 • n=7 Participants	65.8 years STANDARD_DEVIATION 0.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) performance status ECOG 0=Fully Active; No restrictions.	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) performance status ECOG 1= Restricted Strenuous Activity	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Gleason Score Gleason Score ≤ 6	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Gleason Score Gleason Score = 7	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Gleason Score Gleason Score ≥ 8	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: PA2024 ELISPOT counts at Month 24

Population: The immune response population was defined as all randomized subjects who received 3 infusions of sipuleucel-T.

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.

Outcome measures

Outcome measures
Measure	Arm 1: Sipuleucel-T Followed by ADT n=19 Participants 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.	Arm 2: ADT Followed by Sipuleucel-T n=26 Participants 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.
Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024	81.0 IFN-γ ELISPOT (per 300,000 PBMC) Standard Error 28.0	61.1 IFN-γ ELISPOT (per 300,000 PBMC) Standard Error 23.7

SECONDARY outcome

Timeframe: Month 24

Population: The immune response population was defined as all randomized subjects who received 3 infusions of sipuleucel-T.

A participant was considered to have an immune response it the post-baseline PA2024-specific IFN-g ELISPOT count was \>18

Outcome measures

Outcome measures
Measure	Arm 1: Sipuleucel-T Followed by ADT n=33 Participants 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.	Arm 2: ADT Followed by Sipuleucel-T n=34 Participants 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.
Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024	88 percentage of participants	85 percentage of participants

Adverse Events

Arm 1: Sipuleucel-T Followed by ADT

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Arm 2: ADT Followed by Sipuleucel-T

Serious events: 5 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: Sipuleucel-T Followed by ADT n=34 participants at risk 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.	Arm 2: ADT Followed by Sipuleucel-T n=34 participants at risk 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.
Cardiac disorders Coronary artery disease	2.9% 1/34 • Number of events 1 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.	0.00% 0/34 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.
Cardiac disorders Angina pectoris	0.00% 0/34 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.	2.9% 1/34 • Number of events 1 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.
Cardiac disorders Coronary artery occlusion	0.00% 0/34 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.	2.9% 1/34 • Number of events 1 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.
Ear and labyrinth disorders Vertigo	0.00% 0/34 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.	2.9% 1/34 • Number of events 1 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.
General disorders Chest pain	0.00% 0/34 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.	2.9% 1/34 • Number of events 1 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.
Infections and infestations Device-related sepsis	0.00% 0/34 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.	2.9% 1/34 • Number of events 1 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.
Injury, poisoning and procedural complications Post-procedural hemorrhage	0.00% 0/34 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.	2.9% 1/34 • Number of events 1 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.
Nervous system disorders Syncope	0.00% 0/34 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.	2.9% 1/34 • Number of events 1 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.
Nervous system disorders Transient ischaemic attack	0.00% 0/34 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.	2.9% 1/34 • Number of events 1 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/34 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.	2.9% 1/34 • Number of events 1 • All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal. Following Month-6 only possible or probable treatment-related AEs and cerebrovascular events (CVE)s were recorded: Months 9, 12, 15, 18, 21, 24 (and 27 in Arm 1). Adverse events are reported in the safety population defined as subjects who received at least one leukapheresis.

Other adverse events

Additional Information

Shabnam Vaziri

Dendreon

Phone: 206-455-2323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.
Publication restrictions are in place

Restriction type: OTHER