Prostatic Neoplasms, Castration-Resistant
Conditions
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).
Interventions
DRUGJNJ-809
JNJ-809 (1\*10\^9) colony forming units (CFU) given as an infusion.
DRUGApalutamide
Apalutamide 240 mg orally daily.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Prostate-specific Antigen (PSA) Progression | approximately 2 years | Time to PSA progression will be measured using Prostate Cancer Working Group 3 (PCWG3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Progression-free Survival | approximately 2 years | Radiographic progression-free survival, is defined as the time from the date of randomization to the date of radiographic progression or death, whichever occurs first. |
| Time to Unequivocal Clinical Progression | approximately 2 years | Time to unequivocal clinical progression defined as the time from the date of randomization to the date of unequivocal clinical progression as evaluated by the investigator. |
| PSA Doubling Time (PSADT) | approximately 2 years | The PSADT will be determined using the method as recommended by PCWG3 criteria. |
| Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | approximately 2 years | Comparison of the AE profiles of the two treatment groups. |
| Blood Culture and Shedding Profile of JNJ-809 From Cultured Samples of Feces, Urine, and Saliva | approximately 2 years | Blood culture samples will be collected after the mandatory prophylactic antibiotic therapy. Bacterial shedding will be evaluated from cultured samples of feces by stool or rectal swab, urine, and sputum. |
| Overall Survival | approximately 2 years | Overall survival defined as time from the date of randomization to death from any cause. |
Countries
United States
Outcome results
None listed