Trial record 1 of 1 for:
Janssen PCR3003
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
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| ClinicalTrials.gov Identifier: NCT02531516 |
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Recruitment Status :
Active, not recruiting
First Posted : August 24, 2015
Last Update Posted : May 6, 2023
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Sponsor:
Aragon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Aragon Pharmaceuticals, Inc.
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Brief Summary:
The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostatic Neoplasms | Drug: Apalutamide Drug: Bicalutamide Drug: Bicalutamide Placebo Drug: Apalutamide Placebo Drug: GnRH (agonist) Radiation: 74-80 Grays (units of radiation) | Phase 3 |
This is a randomized, double-blind, placebo-controlled, multicenter study of apalutamide plus GnRH agonist compared with GnRH agonist among participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT). The study will include a Screening Phase, Treatment Phase, a Posttreatment Phase, and a Long-term Follow-up Phase. Participants will either receive either apalutamide (experimental) or bicalutamide 50 milligram (mg) capsule plus placebo as control group. Safety will be monitored throughout the study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1503 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy |
| Actual Study Start Date : | November 19, 2015 |
| Estimated Primary Completion Date : | June 28, 2024 |
| Estimated Study Completion Date : | October 6, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
Drug Information available for:
Apalutamide
| Arm | Intervention/treatment |
|---|---|
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Experimental: Apalutamide
Participants will receive apalutamide (240 mg), by mouth, once daily for overall 30 months, plus bicalutamide placebo, by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.
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Drug: Apalutamide Drug: Bicalutamide Placebo Drug: GnRH (agonist) Radiation: 74-80 Grays (units of radiation) |
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Active Comparator: Control group
Participants will receive apalutamide placebo, by mouth, once daily for overall 30 months, plus bicalutamide (50 mg), by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.
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Drug: Bicalutamide Drug: Apalutamide Placebo Drug: GnRH (agonist) Radiation: 74-80 Grays (units of radiation) |
Primary Outcome Measures :
- Metastasis-free survival [ Time Frame: 108 Months ]Metastasis-free survival is defined as the time from randomization to the date of the first occurrence of radiographic bone or soft tissue distant metastasis based on conventional imaging by blinded independent central review (BICR), histopathologic diagnosis of distant metastasis, or death from any cause, whichever occurs first.
Secondary Outcome Measures :
- Event-free Survival [ Time Frame: 108 Months ]Event-free survival is defined as the time from randomization to the date of the first occurrence of prostate specific antigen (PSA) failure by the Phoenix definition, local or regional disease recurrence on conventional imaging by BICR or histopathologic diagnosis, distant metastasis on conventional imaging by BICR or histopathologic diagnosis, or death.
- Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: 108 Months ]Time to PSA progression is defined as time from randomization to the date of PSA nadir plus (+) 0.5 nanograms per milliliter (ng/mL) and rising.
- Overall Survival (OS) [ Time Frame: 108 Months ]OS is defined as the time from randomization to date of death from any cause.
- Time to Distant Metastasis [ Time Frame: 108 Months ]Time to distant metastasis is defined as the time from randomization to the date of the first occurrence of radiographic or pathological bone or soft tissue distant metastasis on conventional imaging by BICR or histopathologic diagnosis of distant metastasis.
- Time to Next Local or Systemic Treatment [ Time Frame: 108 Months ]Time to next local or systemic treatment defined as time from randomization to first subsequent therapy, including re-initiation of androgen deprivation therapy (ADT) and local treatments for local-regional recurrence or distant metastasis.
- MFS by Conventional or Positron Emission Tomography (PET) Imaging [ Time Frame: 108 Months ]MFS by conventional or PET imaging is defined as time from randomization to the date of the first occurrence of radiographic bone or soft tissue distant metastasis based on conventional imaging or PET imaging, histopathologic diagnosis of distant metastasis, or death from any cause, whichever occurs first.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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: 1) Gleason score >=8 and >=cT2c, 2) Gleason score >=7, PSA >=20 nanogram per milliliters (ng/mL), and >=cT2c
- Charlson index (CCI) <=3
- An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1
- Adequate organ function: (1) aspartate aminotransferase (AST), alanine aminotransferase (ALT), within normal limits (WNL), (2) serum creatinine less than (<) 1.5 milligram/deciliter (mg/dL) (<133 micromoles/Liter [mcmol/L]), (3) platelets greater than or equal to (>=)140,000/microLiter (mcL), independent of transfusion and/or growth factors within 3 months prior to randomization, (4) Hemoglobin >= 12.0 gram/deciliter (g/dL) (7.4 millimloes [mmol], independent of transfusion and/or growth factors within 3 months prior to randomization
- 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, (clinical stage M1). Isolated pelvic nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Patients are considered eligible only if the central radiological review confirms clinical stage M0.
- Prior treatment with gonadotropin releasing hormone (GnRH) analogue or anti-androgen or both for >3 months prior to randomization
- Bilateral orchiectomy
- History of pelvic radiation
- Prior systemic (example [e.g.], chemotherapy) or local (e.g. radical prostatectomy, cryotherapy) treatment for prostate cancer
- History of seizure or any 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 (including cyproterone acetate) for prostate cancer
- Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy (e.g., 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 (e.g., 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 anti-epileptic medications for the treatment of seizures
- Gastrointestinal conditions affecting absorption
- Known or suspected contraindications or hypersensitivity to apalutamide, 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531516
Locations
Show 272 study locations
Sponsors and Collaborators
Aragon Pharmaceuticals, Inc.
Investigators
| Study Director: | Aragon Pharmaceuticals, Inc. Clinical Trial | Aragon Pharmaceuticals, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Aragon Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT02531516 |
| Other Study ID Numbers: |
CR106935 56021927PCR3003 ( Other Identifier: Aragon Pharmaceuticals, Inc. ) 2015-003007-38 ( EudraCT Number ) |
| First Posted: | August 24, 2015 Key Record Dates |
| Last Update Posted: | May 6, 2023 |
| Last Verified: | May 2023 |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Aragon Pharmaceuticals, Inc.:
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Prostatic neoplasms Prostate Cancer High-Risk prostate cancer JNJ-56021927 Apalutamide |
ATLAS Radiation Long-term hormone therapy Localized or locally advanced prostate cancer Janssen |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases |
Prostatic Diseases Male Urogenital Diseases Bicalutamide Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents |