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Trial details
A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Prostate-Specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Positive Hormone-Sensitive Prostate Cancer Participants
Current status:
Approved
|
Date registered:
09/05/2021
Trial version(s)
Current: 06/11/2020
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Main Information
Primary registry identifying number
LBCTR2020124661
Protocol number
56021927PCR3015
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Not yet
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Janssen-Cilag International NV
Primary sponsor: Country of origin
Belgium
Public title
A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Prostate-Specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Positive Hormone-Sensitive Prostate Cancer Participants
Acronym
PRIMORDIUM
Scientific title
A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients with PSMA-PET-Positive Hormone-Sensitive Prostate Cancer, with an Observational Follow-up of PSMA-PET-Negative Patients
Acronym
Brief summary of the study: English
The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing agonist (LHRHa) delays metastatic progression as assessed by prostate-specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.
Brief summary of the study: Arabic
الغرض الرئيسي من هذه الدراسة هو تحديد ما إذا كانت إضافة أبالوتاميد إلى العلاج الإشعاعي (RT) بالإضافة إلى ناهض المطلق للهرمون اللوتيني (LHRHa) يؤخر تقدم النقيلي كما تم تقييمه بواسطة التصوير المقطعي بالإصدار البوزيتروني لمستضد البروستاتا (PSMA-PET) أو الموت مقارنة بـ RT + LHRHa وحده.
Health conditions/problem studied: Specify
Prostatic Neoplasms
Interventions: Specify
* Radiation: Radiotherapy * Drug: LHRHa * Drug: Apalutamide
Key inclusion and exclusion criteria: Inclusion criteria
1- Histologically confirmed adenocarcinoma of the prostate 2- Previously treated with radical prostatectomy with lymph node dissection and first postoperative prostate-specific antigen (PSA) measurement of less than (<) 0.1 nanogram/milliliter (ng/mL) between Week 6 and Week 13 3- Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce 4- Prostate-specific membrane antigen-positron emission tomography (PSMA-PET) must be performed at screening: Patients who are PSMA-PET-positive for at least one loco-regional (pelvic) lesion with or without distant (extra-pelvic) lesions at screening, as determined by Blinded Independent Central Review (BICR), will be eligible to be randomized to either arm of the Interventional Cohort. The investigators will be blinded to the location of the PSMA-PET lesions after randomization and patients who are PSMA-PET-negative for any prostate cancer lesions (that is no loco-regional lesion and no distant lesion) at screening, as determined by BICR, will be eligible for inclusion in the Observational Cohort 5- Biochemically recurrent prostate cancer after RP with a high risk of developing metastasis defined as pathological Gleason score greater than or equal to (≥) 8 at diagnosis or time of surgery, OR PSADT less than or equal to (≤) 12 months at the time of screening using at least 3 consecutive values ≥0.1 nanograms per milliliter (ng/mL), from time of BCR, estimated using the Memorial Sloan Kettering Cancer Center online calculator 6- No evidence of metastases on screening CT/MRI of the chest/abdomen/pelvis, Technetium 99m [99mTc] whole-body bone scan. Participants with a single bone lesion on 99mTc whole-body bone scan should have confirmatory imaging by CT or MRI; if the confirmatory scan confirms the bone lesion, the patient should be excluded from the study. Conventional images (99mTc-bone scan and CT/MRI) from the screening will be sent to BICR for confirmation of metastatic disease before randomization 7- Eastern Cooperative Oncology Group Performance Status Grade 0 or 1
Key inclusion and exclusion criteria: Gender
Male
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
1- History of pelvic radiation for malignancy 2- Previous treatment with androgen deprivation therapy (ADT) for prostate cancer 3- Previously treated for biochemical recurrence (BCR) prostate cancer Prior treatment with a CYP17 inhibitor (example, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any androgen receptor (AR) antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy 4- Known or suspected contraindications or hypersensitivity to apalutamide, Luteinizing Hormone-Releasing Hormone (LHRH) agonist or any of the components of the formulations 5- Prior chemotherapy for prostate cancer
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Other
Trial scope: Specify scope
Therapy and Safety
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
Apalutamide (JNJ-56021927)
Type of IMP
Others
Type of IMP: Specify
Chemical
Pharmaceutical class
Antagonist of the androgen receptor (AR)
Therapeutic indication
Recurrent prostate cancer previously treated with radical prostatectomy
Therapeutic benefit
Improve the condition of patients with prostate cancer
Biospecimen retention
Samples with DNA**
Biospecimen description
Blood and tissue (archival tumor samples) samples, retention for up to 15 years
Target sample size
20
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
01/02/2021
Date of study closure: Type
Anticipated
Date of study closure: Date
31/01/2028
Recruitment status
Pending
Date of completion
IPD sharing statement plan
Yes
IPD sharing statement description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinicaltrials.gov
NCT04557059
Sources of Monetary or Material Support
Name
Janssen-Cilag International NV Belgium
Secondary Sponsors
Name
N/A
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Rita
Rizk
Building S2B, Downtown Katameya, Road 90, 5th settlement, New Cairo, 11835, Cairo
Egypt
+96171765042
rita.rizk@iqvia.com
IQVIA
Scientific
Martin
Lukac
Futurama Business Park, Sokolovská 651/136A, Praha 8
Czech Republic
+421 948 155 200
mlukac1@ITS.JNJ.com
Janssen Cilag
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Centre Hospitalier du Nord
Dr. Khalil Armache
Urologist (Genito Urinary Surgery)
Approved
American University of Beirut Medical Center
Dr. Muhammad Bulbul
Urologist
Pending
Notre Dame des Secours Hospital
Dr. Raghid Khoury
Urologist
Approved
Saint George University Hospital Medical Center
Dr. Joseph Makdessi
Urologist
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Centre Hospitalier du Nord
28/10/2020
Mr. Chaybane Makkary
chn@chn.com.lb
009616555230
Notre Dame des Secours Centre Hospitalier Universitaire
29/10/2020
Pere Wissam Khoury
info@chu-nds.org
009619940400
Saint George Hospital University Medical Center
03/12/2020
Dr. Michel Daher
N/A
009611441000
Countries of Recruitment
Name
Austria
Czech Republic
Denmark
Poland
Russian Federation
Spain
Sweden
Turkey
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Prostatic Neoplasms
Prostate (D40.0)
Prostatic Neoplasms, Genital Neoplasms, Male Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Prostatic Diseases
Interventions
Intervention
Description
Keyword
Apalutamide
Participants will receive therapeutic dose of apalutamide 240 mg tablets once daily for 180 Days
Apalutamide
Radiotherapy
Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.
Radiotherapy
LHRHa
Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation at Day 1 and Day 85 or as a 6-monthly depot preparation at Day 1
LHRHa
Primary Outcomes
Name
Time points
Measure
Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS)
Up to 7 years
ppMPFS is defined as the appearance of at least 1 new PSMA-PET-positive distant lesion compared with the previous scan as assessed by blinded independent central review (BICR) or death
Key Secondary Outcomes
Name
Time points
Measure
Time to Prostate-Specific Antigen (PSA) Progression
Up to 7 years
Time to PSA progression is defined as the time from randomization to the date of first documentation of PSA progression. PSA progression is defined as a PSA concentration above the nadir of more than 0.5 nanogram per milliliter (ng/mL), confirmed by repeated measurement at least 3 Weeks later
PSA Response Rate
Up to 7 years
PSA Response Rate is defined as the percentage of participants with a PSA decrease of >= 50% , >=90% or undetectable from baseline
PSA Levels at week 26
Week 26
PSA levels at week 26 will be reported
Time to Loco-Regional Progression by PSMA-PET
Up to 7 years
Time to loco-regional progression by PSMA-PET as assessed by blinded independent central review (BCIR) is defined as the time from randomization to the date of the first occurrence of PSMA-PET loco-regional progression. Criteria for PSMA-PET loco-regional progression: Appearance of at least one new PSMA-PET-positive loco-regional lesion compared with the previous scan
Overall Survival
Up to 7 years
Overall survival is defined as the time from randomization to date of death from any cause.
Prostate Cancer-Specific Survival
Up to 7 years
Prostate cancer-specific survival is defined as the time from randomization to date of death due to prostate cancer.
Number of Participants With Adverse Event (AE) and Serious Adverse Events (SAEs)
Up to 7 years
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial