TITAN 56021927PCR3002

Study StatusEnrolling
ProtocolTitan-56021927PCR3002
Sponsor
Study Description

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of JNJ-56021927 Plus Androgen Deprivation Therapy Versus ADT in Subjects with Low-volume Metastatic Hormone-sensitive Prostate Cancer

Primary Endpoint

Determine if the addition of JNJ-56021927 to ADT provides superior efficacy in improving radiographic progression-free survival or overall survival for subjects with low-volume mHSP 

Inclusion Criteria

-Subject must be a man ≥ 18 years of age, inclusive
-Diagnosis of prostate adenocarcinoma as confirmed by the investigator. For subjects diagnosed >5 years from randomization, histologic evidence of prostate adenocarcinoma from a metastatic lesion is required
-Metastatic disease documented by ≥ bone lesions on Technetium-99m bone scan
-ECOG PS grade of 0,1, or 2
-Castration therapy (medical or surgical must have been started at least 14 days prior to randomization). Subjects who start a GnRHa within 28 days of randomization will be required to take a first-generation anti-androgen for at least 14 days prior to randomization; the anti-androgen must be discontinued prior to randomization. Subjects who received prior docetaxel are not required to have 14 days of a first-generation anti-androgen with the GnRHa
-Allowed prior treatment for prostate cancer:
        *Maximum of 1 course of radiation or surgical intervention
-Subjects who received prior docetaxel:
         *Must have low-volume disease on pre-docetaxel imaging (ie, not meeting
          exclusion criterion #4 prior to docetaxel). The pre-docetaxel bone scan and
          CT/MRI images must be submitted to the central imaging vendor prior to
          randomization
         *Must have received a maximum of 6 cycles of docetaxel for low-volume
           mHSPC with the last dose within 2 months of randomization and must have
           recovered from toxicities associated with docetaxel therapy (ie, hematologic
           and liver function test lab abnormalities). Recovery from docetaxel-related
           neurotoxicity is not required
         *Must not have experienced disease progression between the last dose of
          docetaxel and screening based on investigator assessment of the
          Pre-docetaxel bone scan and CT/MRI scan and screening visits
-Subjects who did not receive prior docetaxel may have received ≤3 months of ADT in the metastatic disease setting prior to randomization. Subjects who received prior docetaxel may have received ≤6 months ADT in the metastatic setting prior to randomization
-May also have received up to 6 months of GnRHa in the adjuvant or neoadjuvant setting as long as it was completed >1 year prior to randomization
-May have received definitive primary therapy (radiation therapy or prostatectomy)
-Able to swallow the while study drug tablets
-To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug
-Each subject must sign an ICF indicating that he understands the purpose of and procedures required for the study, and are willing to participate in the study. Subject must be willing and able to adhere to the prohibitions and restrictions specified in the protocol

Exclusion Criteria

-Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
-Known brain metastases
-Lymph nodes as only site of metastasis
-Visceral (ie, liver or lung) metastasis observed on CT/MRI or ≥4 bone lesions on bone scan with at least 1 lesion beyond the pelvis or vertebral column. (There is no limit to the number of bone lesions allowed if all are confined to the pelvis and vertebral column)
-Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
-Clinical laboratory values during the Screening Phase: Hemoglobin <9.0 g/dL, Neutrophils <1.5 x 10⁹/L, Platelets <100 x 10⁹/L, Total bilirubin >1.5 x upper limit of normal, ALT or AST > 2.5 ULN, Serum creatinine >2.0 x ULN, Serum albumin <3.0 g/dL
-Prior treatment with other second generation anti-androgens (eg enzalutamide), CYP17 inhibitors (abiraterone acetate), immunotherapy (sipuleucel-T), radiopharmaceutical agents or other treatments for prostate cancer except those listed in Inclusion Criterion 6
-Initiation of treatment with a bisphosphonate or denosumab within 28 days prior to randomization
-Medications known to lower seizure threshold must be discontinued or substituted within 28 days of randomization
-Administration of other investigational therapeutic agents, radiation therapy, or invasive surgical procedure (not including castration) within 28 days of randomization or currently enrolled in an investigational study
-Current or prior treatment with anti-epileptic medications for the treatment of seizures. Hx of seizure or condition that may predispose to seizure (including but not limited to prior CVA, TIA, loss of consciousness within 1 year prior to randomization; brain arteriovenous malformation, or intracranial masses such as schwannoma or meningioma that is causing edema or mass effect)
-Current evidence of any of the following: ●Severe/unstable angina, MI, symptomatic CHF, arterial or venous thromboembolic events (PE), or clinically significant ventricular arrhythmias within 6 months prior to randomization ●Uncontrolled HTN (SBP ≥ 160 mmHG or DBP ≥100 mm/Hg). Subjects with a hx of HTN are allowed provided BP is controlled by anti-hypertensive treatment ●GI disorder affecting absorption ●Active infection requiring systemic therapy such as HIV ●Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction ●Subject has known allergies, hypersensitivity, or intolerance to JNJ-56021927 or its excipients ●Any condition or situation that in the opinion of the investigator would preclude participation in the study

Side Effects

JNJ- Fatigue, diarrhea, nausea, skin rash, abdominal pain, changes in thyroid function, constipation, itching, dizziness, hot flashes, insomnia, tremors 

Interested in enrolling in this trial? Please call 717-431-2285.


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