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

NCT04060043 | Completed Early Phase 1

• 1 other identifier: Pepti Pro K02
• Study Type: interventional
• Target: 11
• Locations: 2 countries
• Sites: 7

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 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.

Conditions

Prostate Cancer

Keywords

goserelin; testosterone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in PSA

  84 days

• # of treatment emergent adverse events occurring

  84 days

Study Arms (1)

Goserelin acetate Injection

EXPERIMENTAL

Pepti 10.8mg is a generic formulation of Zoladex® 10.8mg, with the same ingredients (active and excipients), the same formulation, the same dosage, the same size and route of administration.

Drug: Goserelin Acetate

Interventions

Goserelin Acetate DRUG

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.

Also known as: Pepti 10.8mg, Goserelin acetate implant

Goserelin acetate Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CMX Research: lead
• Peptigroupe Inc.: collaborator

Study Sites (7)

Exdeo Clinical Research Inc.

Abbotsford, British Columbia, V2S 3N6, Canada

Location

The Male / Female Health and Research Centre

Barrie, Ontario, L4M 7G1, Canada

Location

Jonathan Giddens Medicine Professional Corporation

Brampton, Ontario, L6T 4S5, Canada

Location

The Fe/Male Health Centres

Oakville, Ontario, L6H 3P1, Canada

Location

Stanley Flax Medical Professional Corporation

Toronto, Ontario, M2J 1V1, Canada

Location

Fridon Todua Research Institute of Clinical Medicine

Tbilisi, 0112, Georgia

Location

MediClubGeorgia

Tbilisi, 0160, Georgia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 16, 2019
• Study Start: February 21, 2017
• Primary Completion: December 6, 2017
• Study Completion: January 2, 2018
• Last Updated: May 10, 2021

Record last verified: 2019-08

Locations

CA (5); GE (2)