A study of Darolutamide in addition to Androgen deprivation therapy in patients with non metastatic castration resistant prostate cancer
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2022/03/041422
- Lead Sponsor
- Bayer Consumer Care AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method