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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04557059




Registration number
NCT04557059
Ethics application status
Date submitted
17/09/2020
Date registered
21/09/2020

Titles & IDs
Public title
A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer
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 Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET With an Observational Cohort
Secondary ID [1] 0 0
56021927PCR3015
Secondary ID [2] 0 0
CR108705
Universal Trial Number (UTN)
Trial acronym
PRIMORDIUM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Radiotherapy
Treatment: Drugs - LHRHa
Treatment: Drugs - Apalutamide

Active comparator: Interventional Cohort (Group 1): RT+ LHRHa - Participants will receive radiotherapy (RT) which is defined as prostate-bed plus pelvic lymph node salvage external-beam radiotherapy with or without optional stereotactic body radiation therapy (SBRT), along with a luteinizing hormone-releasing hormone agonist (LHRHa) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomization.

Experimental: Interventional Cohort (Group 2): RT+LHRHa + Apalutamide - Participants will receive prostate-bed plus pelvic lymph node salvage external-beam radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), along with a LHRHa as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomization. Participants will also receive 240 milligram (mg) of apalutamide starting within 3 days after randomization as film-coated tablets, to be swallowed whole and together once daily with or without food, for a period of 180 Days.

No intervention: Observational Cohort(Group3) PSMA-PET Negative Participants - Enrollment into this cohort will be stopped further. Participants who were PSMA-PET-negative at screening and were already enrolled in the Observational Cohort will continue in this cohort. Data collected in the course of routine clinical practice during this period will include clinical evaluations, disease progression, therapies administered as per standard-of-care at the study-sites and survival status. For Observational Cohort, information will be entered into the electronic case report form (eCRF) from the medical records at least twice a year. The use of any medicinal product(s) for the treatment and management of participants will be at discretion of the treating physician.


Treatment: Other: Radiotherapy
Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.

Treatment: Drugs: LHRHa
Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12 or as a 6-monthly depot preparation within 3 days after randomization.

Treatment: Drugs: Apalutamide
Participants will receive therapeutic dose of apalutamide 240 mg once daily for 180 Days.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS)
Timepoint [1] 0 0
Up to 9 years
Secondary outcome [1] 0 0
Time to Prostate-Specific Antigen (PSA) Progression
Timepoint [1] 0 0
Up to 9 years
Secondary outcome [2] 0 0
PSA Response Rate
Timepoint [2] 0 0
Up to 9 years
Secondary outcome [3] 0 0
PSA Levels at Week 26
Timepoint [3] 0 0
Week 26
Secondary outcome [4] 0 0
Time to Loco-Regional Progression by PSMA-PET
Timepoint [4] 0 0
Up to 9 years
Secondary outcome [5] 0 0
Overall Survival
Timepoint [5] 0 0
Up to 9 years
Secondary outcome [6] 0 0
Prostate Cancer-Specific Survival
Timepoint [6] 0 0
Up to 9 years
Secondary outcome [7] 0 0
Number of Participants With Adverse Event (AE) and Serious Adverse Events (SAEs)
Timepoint [7] 0 0
Up to 9 years

Eligibility
Key inclusion criteria
* Histologically confirmed adenocarcinoma of the prostate
* Previously treated with radical prostatectomy with or without lymph node dissection and either: a) for biochemical recurrence after radical prostatectomy (RP): any post-operative prostate-specific antigen (PSA) measurement of less than (<) 0.1 nanogram/milliliter (ng/mL) within 12 months after RP and without any PSA greater than and equal to (>=) 0.1 ng/mL within the 4 to 8-week period after RP or b) for persistent PSA after RP: PSA >=0.1 ng/mL within the 4 to 8-week period after RP, confirmed by additional measurement at least 3 weeks later
* Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce
* Results of the Prostate specific membrane antigen-positron emission tomography (PSMA-PET) at screening as determined by blinded independent, central review (BICR), must be: PSMA-PET-negative for any prostate cancer lesions (that is, no loco-regional lesion and no distant lesions); or PSMA-PET-positive for at least one loco-regional (pelvic) lesion without distant extra-pelvic lesion; or PSMA PET- positive for at least one loco--regional (pelvic) lesion with extra-pelvic lesion(s).
* High risk of developing metastasis defined as; a) for biochemical recurrence after RP: pathological Gleason score greater than or equal to (>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, or prostate-specific antigen doubling time (PSADT) less than or equal to (<=) 12 months at the time of screening; b) for persistent PSA after RP: pathological Gleason score >=8, evaluated from prostate tissue specimen at radical prostatectomy
* Participants with evidence of distant metastasis on screening PSMA-PET scan must have no evidence of prostate cancer 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 participant should be excluded from the study. Conventional images (99mTc-bone scan and CT/MRI) from the screening will be evaluated locally before randomization
* Eastern Cooperative Oncology Group Performance Status Grade 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* History of pelvic radiation for malignancy
* Previous treatment with androgen deprivation therapy (ADT) for prostate cancer
* Previously treated for biochemical recurrence (BCR) or persistent PSA after RP (previous surgical treatment of one or more loco-regional lesions is allowed)
* 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
* Known or suspected contraindications or hypersensitivity to apalutamide, Luteinizing Hormone-Releasing Hormone (LHRH) agonist or any of the components of the formulations
* Prior chemotherapy for prostate cancer
* Any evidence of prostate cancer metastasis on computed tomography/magnetic resonance imaging (CT/MRI) of the chest/abdomen/pelvis or 99mTc whole-body bone scan, at any time prior to screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/08/2029
Actual
Sample size
Target
Accrual to date
Final
694
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [2] 0 0
Hervey Bay Hospital - Bundaberg
Recruitment hospital [3] 0 0
Epworth Healthcare - East Melbourne
Recruitment hospital [4] 0 0
St Vincent's Hospital - Melbourne - Fitzroy
Recruitment hospital [5] 0 0
Genesis Care Hurstville - Hurstville
Recruitment hospital [6] 0 0
Macquarie University Hospital - North Ryde
Recruitment hospital [7] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [8] 0 0
GenesisCare Wembley - Wembley
Recruitment postcode(s) [1] 0 0
4670 - Bundaberg
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
2220 - Hurstville
Recruitment postcode(s) [5] 0 0
2109 - North Ryde
Recruitment postcode(s) [6] 0 0
2298 - Waratah
Recruitment postcode(s) [7] 0 0
6014 - Wembley
Recruitment outside Australia
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United States of America
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Arizona
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Cadiz
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Ferrol
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Valencia
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Malmö
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Stockholm
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Izmir
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Sakarya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Pharmaceutica N.V., Belgium
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Pharmaceutica N.V., Belgium Clinical Trial
Address 0 0
Janssen Pharmaceutica N.V., Belgium
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04557059