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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05794906




Registration number
NCT05794906
Ethics application status
Date submitted
21/03/2023
Date registered
3/04/2023

Titles & IDs
Public title
A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies
Scientific title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer
Secondary ID [1] 0 0
2022-501343-33-00
Secondary ID [2] 0 0
21492
Universal Trial Number (UTN)
Trial acronym
ARASTEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biochemically Recurrent Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darolutamide (BAY1841788, Nubeqa)
Other interventions - Placebo matching darolutamide
Other interventions - ADT

Experimental: Darolutamide+ADT - Participants will receive darolutamide plus ADT twice daily with food for a pre-specified duration of 24 months.

Placebo comparator: Placebo+ADT - Participants will receive Placebo plus ADT twice daily with food for a pre-specified duration of 24 months.


Treatment: Drugs: Darolutamide (BAY1841788, Nubeqa)
Coated tablet, 300 mg / tablet, oral.

Other interventions: Placebo matching darolutamide
Coated tablet, oral

Other interventions: ADT
Luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonists
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR)
Timepoint [1] 0 0
After randomization to after last treatment, approximately 24 months
Secondary outcome [1] 0 0
Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICR
Timepoint [1] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [2] 0 0
Time to Castration-resistant prostate cancer (CRPC) assessed by investigator
Timepoint [2] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [3] 0 0
Time to initiation of first subsequent systemic antineoplastic therapy
Timepoint [3] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [4] 0 0
Time to loco-regional progression by PSMA PET/CT
Timepoint [4] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [5] 0 0
Time to first Symptomatic skeletal event (SSE)
Timepoint [5] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [6] 0 0
Overall survival (OS)
Timepoint [6] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [7] 0 0
Prostate-specific antigen (PSA) undetectable rates (<0.2 ng/mL)
Timepoint [7] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [8] 0 0
Time to deterioration in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score
Timepoint [8] 0 0
After randomization to after last treatment, approximately 24 months
Secondary outcome [9] 0 0
Time to symptomatic progression
Timepoint [9] 0 0
After randomization to after last treatment, approximately 46 months
Secondary outcome [10] 0 0
Number of participants with Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) categorized by severity
Timepoint [10] 0 0
After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months
Secondary outcome [11] 0 0
Number of participants who discontinue study treatment due to a TEAE
Timepoint [11] 0 0
After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months

Eligibility
Key inclusion criteria
* Capable of giving signed informed consent as described which includes compliance with the requirements, restrictions listed in the informed consent form (ICF), and in this protocol.
* Male =18 years of age at the time of signing the informed consent.
* Histologically or cytologically confirmed adenocarcinoma of prostate.
* Prostate cancer initially treated by: radical prostatectomy (RP) followed by adjuvant radiotherapy (ART), or salvage radiotherapy (SRT), or RP in participants who are unfit for (or refused) ART or SRT, or primary radiotherapy (RT).
* High-risk biochemical recurrence (BCR), defined as Prostate-specific antigen doubling time (PSADT) <12 months calculated using the formula provided by the Sponsor, and PSA =0.2 ng/mL after ART or SRT post RP or after RP in participants who are unfit for ART or SRT (local or central values accepted), or PSA =2 ng/mL above the nadir after primary RT only (local or central values accepted).
* Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 42-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessed by blinded independent central review (BICR) to identify at least one PSMA PET/CT lesion of prostate cancer.
* Serum testosterone =150 ng/dL (5.2 nmol/L) (local assessment is allowed whenever central assessment cannot be done).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Blood counts at screening: Hemoglobin =9.0 g/dL (participant must not have received blood transfusion within 7 days prior to sample being taken); Absolute neutrophil count (ANC) =1.5x10^9/L (participant must not have received any growth factor within 4 weeks prior to sample being taken); Platelet count =100x10^9/L.
* Screening values of: Alanine aminotransferase (ALT) =1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) =1.5 x ULN; Total bilirubin (TBL) =1.5 ULN, (except participants with a diagnosis of Gilbert's disease); Estimated glomerular filtration rate (eGFR) >40 ml/min/1.73 m^2 calculated by the CKD-EPI formula.
* Sexually active male participants must agree to use contraception as detailed in the protocol during the Treatment period and for at least 1 week after the last dose of study treatment, and refrain from donating sperm during this period.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Pathological finding consistent with small cell, ductal or =50 % component of neuroendocrine carcinoma of the prostate.
* History of bilateral orchiectomy.
* Metastases or recurrent /new malignant lesions in prostate gland/bed seminal vesicles, lymph nodes below the CIA bifurcation on conventional imaging (CI) as assessed by BICR during screening.
* Brain metastasis on PSMA PET /CT by BICR at screening.
* High-risk BCR after primary radiotherapy with new loco-regional lesions on screening PSMA PET/CT who are eligible for curative salvage prostatectomy.

Note: Participants treated with curative salvage prostatectomy after primary RT who meet the PSA criteria (inclusion criteria 5) may be considered for the study.

* Prior treatment with second generation (e.g. enzalutamide, apalutamide) androgen receptor inhibitors (ARIs) and CYP 17 inhibitors (e.g., abiraterone) within 18 months prior to signing of the ICF.
* Prior treatments with PSMA-radiotherapeutics within 12 months prior to randomization.
* Prior radiotherapy (including image-guided radiotherapy) as primary, adjuvant or salvage treatment completed within 8 weeks prior to signing of the ICF.
* 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.
* History of pelvic radiotherapy for other malignancy.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2029
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktownn
Recruitment hospital [2] 0 0
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre - Liverpool
Recruitment hospital [3] 0 0
Macquarie University Hospital - Macquarie University
Recruitment hospital [4] 0 0
GenesisCare Newcastle - Newcastle
Recruitment hospital [5] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [6] 0 0
Chris O'Brien Lifehouse - Randwick
Recruitment hospital [7] 0 0
St Vincents Hospital Sydney - Sydney
Recruitment hospital [8] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [9] 0 0
Westmead Hospital - Westmead
Recruitment hospital [10] 0 0
Royal Brisbane & Women's Hospital - Brisbane
Recruitment hospital [11] 0 0
Bundaberg Hospital, Genesis Cancer Care - Bundaberg - Bundaberg
Recruitment hospital [12] 0 0
Wide Bay Hospital and Health Service - Hervey Bay Hospital - Pialba
Recruitment hospital [13] 0 0
Tasman Health Care - Southport
Recruitment hospital [14] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [15] 0 0
Eastern Clinical Research Unit - Box Hill - Box Hill
Recruitment hospital [16] 0 0
Northern Hospital - Epping
Recruitment hospital [17] 0 0
Barwon Health - Geelong
Recruitment hospital [18] 0 0
Austin Health - Heidelberg
Recruitment hospital [19] 0 0
Cabrini Malvern - Malvern
Recruitment hospital [20] 0 0
Western Urology - Maribyrnong
Recruitment hospital [21] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [22] 0 0
Epworth HealthCare - Richmond
Recruitment hospital [23] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [24] 0 0
Prince of Wales Hospital NSW - Randwick
Recruitment postcode(s) [1] 0 0
2148 - Blacktownn
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2109 - Macquarie University
Recruitment postcode(s) [4] 0 0
2290 - Newcastle
Recruitment postcode(s) [5] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [6] 0 0
2031 - Randwick
Recruitment postcode(s) [7] 0 0
2010 - Sydney
Recruitment postcode(s) [8] 0 0
2076 - Wahroonga
Recruitment postcode(s) [9] 0 0
2145 - Westmead
Recruitment postcode(s) [10] 0 0
4029 - Brisbane
Recruitment postcode(s) [11] 0 0
4670 - Bundaberg
Recruitment postcode(s) [12] 0 0
4655 - Pialba
Recruitment postcode(s) [13] 0 0
4215 - Southport
Recruitment postcode(s) [14] 0 0
5000 - Adelaide
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3128 - Box Hill
Recruitment postcode(s) [16] 0 0
3076 - Epping
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3220 - Geelong
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3084 - Heidelberg
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3144 - Malvern
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3032 - Maribyrnong
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3050 - Parkville
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3121 - Richmond
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6009 - Nedlands
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State/province [165] 0 0
A Coruña
Country [166] 0 0
Spain
State/province [166] 0 0
Cantabria
Country [167] 0 0
Spain
State/province [167] 0 0
Málaga
Country [168] 0 0
Spain
State/province [168] 0 0
Barcelona
Country [169] 0 0
Spain
State/province [169] 0 0
Cadiz
Country [170] 0 0
Spain
State/province [170] 0 0
Madrid
Country [171] 0 0
Spain
State/province [171] 0 0
Murcia
Country [172] 0 0
Spain
State/province [172] 0 0
Sevilla
Country [173] 0 0
Spain
State/province [173] 0 0
Valencia
Country [174] 0 0
Sweden
State/province [174] 0 0
Gothenburg
Country [175] 0 0
Sweden
State/province [175] 0 0
Malmo
Country [176] 0 0
Sweden
State/province [176] 0 0
Uppsala
Country [177] 0 0
Taiwan
State/province [177] 0 0
Taichung
Country [178] 0 0
Taiwan
State/province [178] 0 0
Taipei
Country [179] 0 0
Taiwan
State/province [179] 0 0
Taoyuan
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Bedfordshire
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Middlesex
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Surrey
Country [183] 0 0
United Kingdom
State/province [183] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
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)?
No
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.


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/NCT05794906