Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Pilot Study to Evaluate the Effects of a New Depot Formulation of Goserelin Acetate 10.8 mg, on Testosterone Levels in Ambulatory Patients With Carcinoma of the Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04060043
• Other study ID #: Pepti Pro K02
• Status: Completed
• Phase: Early Phase 1
• Start date: February 21, 2017
• Est. completion date: January 2, 2018

Study information

• Verified date: August 2019
• Source: CMX Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.

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 patient's eligibility will be evaluated and baseline assessments will be performed. Eligible patients will sign the informed consent form at this visit.

Within 2 weeks after the screening visit, eligible patients will receive a subcutaneous injection of Pepti 10.8mg on day 0 (V2) and samples will be collected for goserelin 1h, 1.5h, 2h and 3h after the injection. Monitoring of the effects for approximate 4h after the injection will be performed.

Thereafter, patients will return to the clinic for follow-up visits approximately every 2 weeks (Visit 3 to 9: Day 7, 21, 35, 49, 63, 77 and 84). The follow-up visits are planned to enable repeated blood sampling designed to evaluate the testosterone response, safety profile and PSA response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2, 2018
• Est. primary completion date: December 6, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Goserelin Acetate
The Pepti 10.8mg (goserelin acetate) implant is supplied as a cylindrical rod of biodegradable and biocompatible D, L Lactic and glycolic acids copolymer. Each implant contains goserelin acetate equivalent to 10.8mg of goserelin as well as a blend of high and low molecular weight range of D, L lactic and glycolic acids copolymer to total a weight of approximately 36.0mg per depot. The implant will be injected subcutaneously through the patient's anterior abdominal wall.

Locations

Country	Name	City	State
Canada	Exdeo Clinical Research Inc.	Abbotsford	British Columbia
Canada	The Male / Female Health and Research Centre	Barrie	Ontario
Canada	Jonathan Giddens Medicine Professional Corporation	Brampton	Ontario
Canada	The Fe/Male Health Centres	Oakville	Ontario
Canada	Stanley Flax Medical Professional Corporation	Toronto	Ontario
Georgia	Fridon Todua Research Institute of Clinical Medicine	Tbilisi
Georgia	MediClubGeorgia	Tbilisi

Sponsors (2)

Lead Sponsor	Collaborator
CMX Research	Peptigroupe Inc.

Countries where clinical trial is conducted

Canada,  Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in testosterone levels	To evaluate the effects of one Pepti implant on testosterone serum concentration from day 0 to day 84	84 days
Secondary	Changes in PSA	To assess the changes in blood PSA (Prostate Specific Antigen) levels from PSA laboratory results. This testing is to be performed to assess whether patients can be considered for continuing treatment with an LHRH analogue.	84 days
Secondary	# of treatment emergent adverse events occurring	To assess the safety profile of depot formulation of Pepti 10.8mg from day 0 to day 84, all adverse events will be recorded.	84 days