NCT02906605

Brief Summary

The purpose of this study is to evaluate if the anti-tumor activity of JNJ-809 combined with apalutamide is improved compared with apalutamide alone for subjects with metastatic castration-resistant prostate cancer (mCRPC).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

1.9 years

First QC Date

September 15, 2016

Last Update Submit

November 18, 2016

Conditions

Prostatic Neoplasms, Castration-Resistant

Outcome Measures

Primary Outcomes (1)

  • Time to Prostate-specific Antigen (PSA) Progression

    Time to PSA progression will be measured using Prostate Cancer Working Group 3 (PCWG3).

    approximately 2 years

Secondary Outcomes (6)

  • PSA Doubling Time (PSADT)

    approximately 2 years

  • Radiographic Progression-free Survival

    approximately 2 years

  • Time to Unequivocal Clinical Progression

    approximately 2 years

  • Overall Survival

    approximately 2 years

  • Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

    approximately 2 years

  • +1 more secondary outcomes

Study Arms (2)

JNJ-809 plus Apalutamide (Group A)

EXPERIMENTAL

JNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily.

Drug: JNJ-809Drug: Apalutamide

Apalutamide (Group B)

EXPERIMENTAL

Apalutamide 240 mg orally daily.

Drug: Apalutamide

Interventions

JNJ-809DRUG

JNJ-809 (1\*10\^9) colony forming units (CFU) given as an infusion.

JNJ-809 plus Apalutamide (Group A)
ApalutamideDRUG

Apalutamide 240 mg orally daily.

Apalutamide (Group B)JNJ-809 plus Apalutamide (Group A)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adenocarcinoma of the prostate
  • Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans
  • Surgically or medically castrated, with testosterone levels of less than (\<)50 nanogram per deciliter (ng/dL)
  • Castration-resistant prostate cancer documented by time to prostate-specific antigen (PSA) increase during continuous treatment with androgen deprivation therapy (ADT) OR radiographic progression of soft tissues OR radiographic progression of bone according to PCWG3

You may not qualify if:

  • Predominately small cell or neuroendocrine carcinoma of the prostate
  • Known brain metastases (even if treated) or untreated epidural spread
  • Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting, or up to 6 cycles of docetaxel for metastatic hormone-sensitive prostate cancer
  • Treatment with medications known to lower the seizure threshold or any investigational agent that were not discontinued or substituted greater than or equal to (\>=)28 days prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

New York, New York, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

apalutamide

Condition Hierarchy (Ancestors)

Prostatic NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 20, 2016

Study Start

October 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations

US(1)