Status:
COMPLETED
Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer
Lead Sponsor:
CMX Research
Collaborating Sponsors:
Peptigroupe Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the op...
Detailed Description
A 12 week (84 day) single injection study in 12 patients with carcinoma of the prostate. During the screening phase, all patients will come to the clinic for a screening visit (V1), during which the ...
Eligibility Criteria
Inclusion
- Be male at least 18 years of age
- Be an ambulatory patient with carcinoma of the prostate (high risk localized or metastatic) documented by available prostate biopsy information, who in the opinion of the treating physician, is a candidate for androgen deprivation therapy
- Have a testosterone level \> 1.5ng/mL or \>5nmol/L at screening
- Have a life expectancy of at least 1 year
- Have the ability to understand the requirements of the study and is willing to provide written informed consent
- Agree to abide by the study restrictions and return for the required assessments
- only patients who can be discontinued safety from contra-indicated medications discussed in section 7.4 of the protocol can be included in the study
Exclusion
- Have brain metastases
- Have vertebral metastases with evidence of spinal cord compression
- Have renal impairment due to ureteric obstruction or a history of obstructive uropathy
- Have excruciating, sever bone pain due to extensive bone metastases (however, concomitant therapy with either flutamide or bicalutamide is permitted and encouraged during the first month of the study, in the case where mile bone metastasis are present or suspected)
- Undergone orchiectomy, adrenalectomy or hypophysectomy
- Have undergone prostatic surgical procedures (e.g. radical prostatectomy, transurethral resection of the prostate) within the last month
- Have undergone localized external beam radiotherapy, brachytherapy, thermotherapy or cryotherapy within the last 4 weeks
- Undergone systemic chemotherapy, immunotherapy (e.g. antibody therapies, tumor-vaccines) or biological response modifiers (e.g. cytokines) within the last 3 months
- Have been treated with 5-alpha-reductase inhibitors (e.g finasteride (Proscar®, Propecia®), dutasteride (Avodart®)) within the last month
- Have been previously treated with luteinizing hormone releasing hormone agonists (LHRHa) (e.g. leuprolide (Lupron®), goserelin (Zoladex®) etc.) except if their testosterone levels are above 5 nmol/L and the patient in a known responder
- Have and ongoing treatment with androgen receptor (AR) blockers (e.g. megestrol (Megace®) or cyproterone (Androcur®). Note: Treatment with bicalutamide (Casodex®) IS permitted.
- Have a known hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonists, any Luteinizing Hormone-Releasing Hormone (LHRH) agonists (e.g. leuprolide (Lupron®), goserelin (Zoladex®) etc.) or to the poly(lactic-co-glycolic acid (PLGA)) polymers contained in the study formulation
- Have a liver disease (e.g. cirrhosis, chronic active hepatitis or chronic persistent hepatitis) or has persistent alanine amino-transferase (ALT), aspartate amino-transferase (AST) \> 2 X upper limit normal (ULN), serum creatinine \> 2 X ULN, serum bilirubin \> 2 X ULN
- Have received an investigational drug or participated in a clinical trial within the last 30 days
- Have a clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
- Have a body mass index (BMI) \< 18.5
- Be an anticoagulated patient with an International Normalized Ratio (INR) ≥ 2
- Have a history of QT prolongation, congenital long QT syndrome, electrolyte abnormalities, Congestive Heart Failure (CHF), or concurrent administration with QT prolonging drugs or QTc \> 450 msec
Key Trial Info
Start Date :
February 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2018
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04060043
Start Date
February 21 2017
End Date
January 2 2018
Last Update
May 10 2021
Active Locations (7)
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1
Exdeo Clinical Research Inc.
Abbotsford, British Columbia, Canada, V2S 3N6
2
The Male / Female Health and Research Centre
Barrie, Ontario, Canada, L4M 7G1
3
Jonathan Giddens Medicine Professional Corporation
Brampton, Ontario, Canada, L6T 4S5
4
The Fe/Male Health Centres
Oakville, Ontario, Canada, L6H 3P1