CTRI/2022/03/041422 [Registered on: 28/03/2022] Trial Registered Prospectively
Last Modified On:
09/06/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A study of Darolutamide in addition to Androgen deprivation therapy in patients with non metastatic castration resistant prostate cancer
Scientific Title of Study
A single-arm, open-label Phase 4 study of
darolutamide in addition to standard androgen
deprivation therapy for participants in India with highrisk
non-metastatic castration-resistant prostate cancer
(nmCRPC)
Bayer Pharmaceuticals Private Limited,
Research & Development Pharmaceuticals,
Bayer House, Central Avenue, Hiranandani Estate,
Thane - 400607, Maharashtra, India
Bayer Pharmaceuticals Private Limited,
Research & Development Pharmaceuticals,
Bayer House, Central Avenue, Hiranandani Estate,
Thane - 400607, Maharashtra, India
Thane MAHARASHTRA 400607 India
Phone
02225311201
Fax
Email
ashish.gawde@bayer.com
Source of Monetary or Material Support
Bayer Consumer Care AG
Primary Sponsor
Name
Bayer Consumer Care AG
Address
Bayer Consumer Care AG, Peter-Merian-
Strasse 84, 4052 Basel, Switzerland
Room no. 133, Dr. Bhimrao Ambedkar, Institute of Rotary Cancer Hospital (DR. BRA IRCH), All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi - 110029, Delhi, India
New Delhi DELHI
9868332019
drhareshkp@gmail.com
Dr Ginil Kumar Polleri
Amrita Institute of Medical Sciences and Research Centre
Amrita Institute of Medical Sciences and Research Centre, AIMS Ponekkara, Kochi - 682041, Kerala Ernakulam KERALA
9895071039
drginil@aims.amrita.edu
Dr Sanjai Kumar Addla
Apollo Cancer Hospitals
Apollo Cancer Hospitals, Apollo Hospitals, Jubilee Hills, Hyderabad, Telangana 500096, India Hyderabad TELANGANA
9000322220
skaddla@gmail.com
Dr Aseem Kumar Samar
Bhagwan Mahaveer Cancer Hospital & Research Centre
Bhagwan Mahaveer Cancer Hospital & Research Centre, Jawahar Lal Nehru Marg, Jaipur-302017(Raj), India
Jaipur RAJASTHAN
9004399604 0141-2709716 aseemtmh@gmail.com
Dr Rajeev Sood
Dr. RML Hospital & PGIMER
Department of Urology & Renal Transplant, Room no. 31, OPD Block, Ground Floor, ABVIMS & Dr RML Hospital, Baba Kharag Singh Marg, New Delhi – 110001 (India)
New Delhi DELHI
9810005182
drsoodr@gmail.com
Dr Satheesh CT
HealthCare Global Enterprises Limited
HealthCare Global Enterprises Limited, No 8, HCG Towers, P. Kalinga Rao Road, Sampangi Ram Nagar, Bengaluru, Karnataka- 560027 Bangalore KARNATAKA
9242698750
drsatheesh.ct@hcgel.com
Dr Smita Kayal
Jawaharlal Institute of Postgraduate Medical Education & Research
Additional Professor, Department of Medical Oncology, RCC, JIPMER, Puducherry - 605006.
Pondicherry PONDICHERRY
7598118439
kayalsmita@gmail.com
Dr Akhil Kapoor
Mahamana Pandit Madan Mohan Malaviya cancer centre (MPMMCC)
(1) ICD-10 Condition: C61||Malignant neoplasm of prostate,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Darolutamide BAY 1841788
Approximately 50 participants will be enrolled to receive darolutamide 600 mg (two 300 mg tablets) taken orally, twice daily (BID), equivalent to a total daily dose of 1200 mg.
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Male
Details
1. Capable of giving signed IC which
includes compliance with the requirements, restrictions listed in the informed consent
form (ICF), and in this protocol; and providing signed IC.
2. Participant must be male aged ≥ 18 years.
3. Histologically or cytologically confirmed adenocarcinoma of prostate without
neuroendocrine differentiation or small cell features.
4. CRPC defined as 3 rising PSA levels after the nadir taken at least 1 week apart during
ADT. If the participant has a history of antiandrogen use, the most recent PSA value
must be obtained at least 4 weeks after antiandrogen withdrawal.
5. Castrate level of serum testosterone (< 1.7 nmol/L [50 ng/dL]) on gonadotropin
releasing hormone (GnRH) agonist or antagonist therapy or after bilateral
orchiectomy. Participants who have not undergone bilateral orchiectomy must
continue GnRH therapy during the study.
6. PSADT of ≤ 10 months and PSA ≥ 2 ng/mL at screening.
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
8. Estimated glomerular filtration rate (eGFR) > 15 mL/min/1.73 m2
9. Blood counts at screening: hemoglobin ≥ 9.0 g/dL, absolute neutrophil count
≥ 1500/μL (1.5 × 109/L), platelet count ≥ 100,000/μL (100 ×109/L) (participant must
not have received any growth factor or blood transfusion within 7 days of the
hematology laboratory obtained at screening).
10. Screening values of serum alanine aminotransferase (ALT) and aspartate transaminase
(AST) ≤ 2.5 × upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN (except
participants with a diagnosis of Gilbert’s disease), creatinine ≤ 2.0 × ULN.
11. Sexually active participants, unless surgically sterile, must agree to use a male condom
plus partner use of a contraceptive method with a failure rate of <1% per year, and refrain from sperm
donation during the study treatment and for 1 week after the last dose of study
treatment. Contraceptive use by men should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
ExclusionCriteria
Details
1. History of metastatic disease at any time or presence of detectable metastases by
investigator assessment within 42 days prior to start of study treatment. Presence of
pelvic lymph nodes < 1.5 cm in short axis below the aortic bifurcation is allowed.
2. Symptomatic local-regional disease that requires medical intervention including
moderate/severe urinary obstruction or hydronephrosis due to prostate cancer.
3. Acute toxicities of prior treatments and procedures not resolved to Common
Terminology Criteria for Adverse Events (CTCAE) v.4.03 grade ≤ 1 or baseline before
first dose of study treatment.
4. Severe or uncontrolled concurrent disease, infection, or co-morbidity that, in the
opinion of the investigator, would make the participant inappropriate for enrollment.
5. Known hypersensitivity to the study treatment or any of its ingredients.
6. Major surgery within 28 days before first dose of study treatment.
7. Any of the following within 6 months before first dose of study treatment: stroke,
myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery
bypass graft; congestive heart failure New York Heart Association Class III or IV.
8. Uncontrolled hypertension as indicated by a systolic blood pressure (BP) ≥ 160 mmHg
or diastolic BP ≥ 100 mmHg at screening despite medical management. Participants
with hypertension can enroll provided BP is stable and controlled by anti-hypertensive
treatment.
9. End-stage renal disease (eGFR < 15 mL/min/1.73 m2).
10. Prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or
superficial bladder cancer that has not spread behind the connective tissue layer (i.e.,
pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has
been completed ≥ 5 years ago and from which the participant has been disease-free.
11. Gastrointestinal disorder or procedure which expects to interfere significantly with
absorption of study treatment.
12. Unstable active viral hepatitis with a need for treatment.
13. Known human immunodeficiency virus (HIV) infection with any of the following
(Note: HIV testing is not required unless mandated by local authority):
CD4+ T-cell (CD4+) count of less than 350 cells/μL
History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic
infection within the past 12 months
On established antiretroviral therapy for less than 4 weeks
Presenting with a viral load of more than 400 copies/mL prior to enrollment
On antiretroviral therapy or prophylactic antimicrobials that are expected to cause
significant drug-drug interactions or overlapping toxicities with study treatment
and cannot be changed to alternative agents.
14. Any condition that, in the opinion of the investigator, would impair the participants’
ability to comply with the study procedures or study treatment (e.g., unable to swallow
study treatment).
15. Unwilling or unable to comply with all protocol-required visits and assessments or
comply with study requirements.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Incidence and severity of AEs and SAEs
Incidence of discontinuations and dose
modifications of study treatment due to
AEs
Laboratory, physical examination, and
ECG abnormalities reported as AEs
Changes in vital signs
Changes in ECOG performance status
From the start of darolutamide treatment up to 30
days after the last dose of
darolutamide.
Secondary Outcome
Outcome
TimePoints
PSA percent change from baseline at
16 weeks
PSA maximum percent decline from
baseline at any time on study treatment
Time to initiation of first subsequent
antineoplastic therapy
Time to initiation of first cytotoxic
chemotherapy for prostate cancer
All participants will visit the study center at Day 1, Week 16, and every 16 weeks
thereafter. Participants will remain on study treatment until disease progression,
death, consent withdrawal, lost to follow-up, or until any criteria for treatment withdrawal is
met. At which
time, an EoT visit will be performed 30 days after the last dose of study treatment.
Target Sample Size
Total Sample Size="50" Sample Size from India="50" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"