euprolide acetate in the treatment of Prostate Cancer.
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2023/09/057619
- Lead Sponsor
- Pharmathen S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Male patients between age group of 18 and 75 years (both inclusive) and having a BMI of 18.5-30 kg/m2 (both inclusive).
2.Ability to understand and provide written informed consent prior to participation in the study and willing to comply with the study requirements as per protocol.
3.Patients who require Leuprolide Acetate Depot Injection, 30 mg every 16 weeks.
4.Patients with histologically/cytologically confirmed advanced carcinoma of prostate (Stage T(1b-4), N(any) , M(any)) who would be benefit from GnRH agonist .
5.Newly diagnosed advanced prostatic cancer patients that are undergoing initial therapy of leuprolide acetate 30 mg.
6.Testosterone levels = 1.5ng/mL at screening.
7.Patients with an ECOG Performance Status Score < 2.
8.Patients with hemoglobin = 9.0 g/dL .
9.No history of addiction to any recreational drug or drug dependence or alcohol addiction.
10.Non-smoker or ex-smoker who has not used any nicotine containing products in the last 6 months before day 1 of study treatment.
11.Patients with HbA1c = 7 % at screening.
12.Patients with life expectancy of at least 6 months at the time of enrolment as judged by Investigator.
13.Patients/ partner agreeing to use adequate contraceptive methods during the study.
1.Known hypersensitivity or contraindication to GnRH, GnRH agonist or to any of the components of investigational product.
2.History of prostatic surgery (e.g., radical prostatectomy, transurethral resection of the prostate [TUR-P]) ,orchiectomy, adrenalectomy and hypophysectomy.
3.History of radiotherapy, chemotherapy, immunotherapy, radiation therapy, cryotherapy, strontium, or biological response modifiers as prostate therapy within 8 weeks prior the screening visit .
4.Patients that received hormonal manipulation within 32 weeks prior the screening visit (i.e. GnRH analogues, estrogen, megace and phytotherapy).
5.Patients requiring additional treatment (i.e. radiotherapy).
6.History of hypogonadism.
7.Received therapy with finasteride or ketoconazole within 1 week prior to the Screening Visit; dutasteride within 25 weeks prior to the Screening Visit.
8.Received therapy with a GnRH analog (1-year implant) within 60 weeks prior to the Screening Visit.
9.Positive tests for drug or alcohol abuse at screening or check in.
10.Patient had major surgery (other than those specified in criteria 2) within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
11.Participants with inadequate mass in the gluteal to receive the intramuscular drug injection.
12.Patients with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
13.History of difficulty with donating blood or difficulty in accessibility of veins.
14.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
15.Clinical indication of urinary tract obstruction.
16.History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
17.Significant pre-existing cardiovascular co morbidities i.e. Myocardial infarction within 6 month prior to screening, Unstable angina, Congestive cardiac failure, Cardiac arrhythmia, History of familial long QT syndrome.
18.Known CNS metastasis.
19.Patients having history of convulsion, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs.
20.Concurrent medications that may prolong the QT/QTc interval.
21.A marked baseline prolongation of QTc interval (QTc interval >450 milliseconds (ms) QTc interval to be calculated with Bazett’s Formula).
22.History of other malignancies in the last 5 years (except in situ cancer of cervix or basal or squamous cell skin cancer).
23.Participation in any clinical study within 90 days prior to receiving the first dose of Investigational Product.
24.Any condition/ abnormal baseline findings that in the investigators’ judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study e.g. low expectation of compliance to dosing or expected changes in concomitant medication that may interfere in study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the comparative bioavailability between Leuprolide acetate for depot suspension 30 mg for 4-month administration of Pharmathen S.A., Greece & LUPRON DEPOT (Leuprolide Acetate for Depot Suspension) 30 mg for 4-month administration of AbbVie Inc. North Chicago, IL 60064 in adult male subjects with advanced prostatic cancer undergoing initial therapy of leuprolide acetate 30 mg under fasting conditions.Timepoint: Total 36 PK sampling done pre & post dose at 0.0, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 12.00, 18.00, 24.00 (Day 2), 48.00 (Day 3), 72.00 (Day 4), 120.00 (Day 5), 168.00 (Day 8), 336.00 (Day 15), 504.00 (Day 22), 672.00 (Day 29), 840.00 (Day 36), 1008.00 (Day 43), 1176.00 (Day 50), 1344.00 (Day 57), 1512.00 (Day 64), 1680.00 (Day 71), 2016.00 (Day 85), 2352.00 (Day 99), 2688.00 (Day113) hours.
- Secondary Outcome Measures
Name Time Method To monitor the adverse events & to ensure the safety of patients exposed to Investigational Medicinal Product.Timepoint: Visit 1: Screening visit (up to 14 days prior to first day of dosing) <br/ ><br>Visit 2: Eligibility / Randomization visit (check in day 0) <br/ ><br>Visit 3-17: Ambulatory PK sample collection visit (On days 3, 4, 5, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85, 99). <br/ ><br>Visit 18: End of study visit: Ambulatory PK sample collection visit (on day 113) & safety assessment.