A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy

Phase 3

Completed

• Conditions: 10036958; prostate cancer or high- risk Localized or Locally Advanced PC

• Registration Number: NL-OMON53090
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Age >=18 years
- Indicated and planned to receive primary radiation therapy for prostate cancer
-Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the
following at
diagnosis:
• Gleason score >=8 and >=cT2c stage per AJCC 8th Edition
• Gleason score 7, PSA >=20 ng/mL, and >=cT2c stage per AJCC
- Charlson comorbidity index (CCI) <=3
- An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of
0 or 1
- Adequate liver function: aspartate aminotransferase (AST), alanine
aminotransferase (ALT), <2 x upper limit of normal (ULN) and total bilirubin
<1.5 x ULN
- Participants who are sexually active (even men with vasectomies) and willing
to use a condom and agree not to donate sperm during the trial
- Signed, written, informed consent
- Be able to swallow whole study drug tablets

Exclusion Criteria

- Presence of distant metastasis, including pelvic nodal disease below the
iliac bifurcation >2 cm in the short axis
- Prior treatment with GnRH analogue or antiandrogen or both for >3 months
prior to randomization
- Bilateral orchiectomy
- History of pelvic radiation
- Prior systemic (eg, chemotherapy) or procedural (eg, prostatectomy,
cryotherapy) treatment for prostate cancer
- History of seizure or condition that may predispose to seizure (including,
but not limited to prior stroke, transient ischemic attack or loss of
consciousness <=1 year prior to randomization* brain arteriovenous malformation*
or intracranial masses such as schwannomas and meningiomas that are causing
edema or mass effect)
- Prior treatment with enzalutamide, abiraterone acetate, orteronel,
galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and
progestational agents for prostate cancer
- Prior treatment with radiopharmaceutical agents (eg, strontium 89) or
immunotherapy (eg, sipuleucel-T) for prostate cancer
- Prior treatment with systemic glucocorticoids <=4 weeks prior to randomization
or is expected to require long-term use of corticosteroids during the study
- Use of 5-alpha reductase inhibitors (eg, dutasteride, finasteride) <=4 weeks
prior to randomization
- Use of any investigational agent <=4 weeks prior to randomization
- Current chronic use of opioid analgesics for >=3 weeks for oral or >= 7 days
for non-oral formulations
- Major surgery <=4 weeks prior to randomization
- Current or prior treatment with antiepileptic medications for the treatment
of seizures
- Gastrointestinal conditions affecting absorption
- Known or suspected contraindications or hypersensitivity to JNJ-56021927,
bicalutamide or GnRH agonists or any of the components of the formulations
- Any condition for which, in the opinion of the investigator, participation
would not be in the best interest of the subject

Study & Design

• Study Type: Interventional
• Study Design: Not specified