Degarelix Neo-Adjuvant Radical Prostatectomy Trial

NCT01674270 | Completed Phase 2 DMC

• 2 other identifiers: DEG_PRE-OP_001Degarelix Pre-Op
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on intratumoral levels of androgens.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Intratumoral androgen levels

  Week 12

Secondary Outcomes (1)

• Prostate tumour morphology related to androgen withdrawal after neo-adjuvant therapy

  Week 12

Other Outcomes (3)

• Serum levels of Androgen Receptor after neo-adjuvant therapy

  Baseline, Week 12

• Serum level of Follicle Stimulating Hormone (FSH) after neo-adjuvant therapy

  Baseline, Week 12

• Serum Level of Inhibin-b and GnRH after neo-adjuvant therapy

  Baseline, Week 12

Study Arms (3)

Degarelix

EXPERIMENTAL

Degarelix Alone

Drug: Degarelix

Degarelix + Casodex

EXPERIMENTAL

Degarelix and Casodex

Drug: Degarelix; Drug: Casodex

LHRH Agonist + Casodex

ACTIVE COMPARATOR

LHRH Agonist and Casodex

Drug: Casodex; Drug: LHRH Agonist

Interventions

Degarelix DRUG

Degarelix; Degarelix + Casodex

Casodex DRUG

Degarelix + Casodex; LHRH Agonist + Casodex

LHRH Agonist DRUG

LHRH Agonist + Casodex

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men \>18 and =\< 75 years of age
• Willing and able to provide informed consent, either alone or with the aid of a translator
• Histologically confirmed prostate cancer as determined by transrectal ultrasound (TRUS) guided prostate biopsy performed within 6 months of study enrolment
• Gleason Score \>= 7and/or prostate cancer that is clinical stage T2 disease.
• Candidates for open radical prostatectomy considered surgically resectable by urologic evaluation
• Normal organ and marrow function as defined by the following criteria:
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

You may not qualify if:

• Previous or current use of hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, and ketoconazole)
• History of receiving radiation to the pelvic area.
• Previously received therapy with 5-alpha reductase inhibitors finasteride and/or dutasteride 4 weeks prior to randomization.
• History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
• History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
• Known hypersensitivity towards any component of the investigational medicinal product or Casodex (bicalutamide) or their excipients.
• Marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval \>450 ms).
• History of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome).
• Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
• Clinically significant laboratory abnormalities (e.g. severe renal or hepatic impairment) which in the judgment of the Investigator would affect the patient's health or the outcome of the trial.
• Clinically significant disorder (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
• Use of natural medicines thought to have endocrine effects on prostate cancer (e.g. saw palmetto and St. John's Wort) 4 weeks prior to randomization.
• Mental incapacity or language barrier precluding adequate understanding or co operation.
• Use of an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial.
• Previously participated in any degarelix trial.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (2)

• Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

  PMID: 34350976 DERIVED

• Sayyid RK, Evans A, Hersey K, Maloni R, Hurtado-Coll A, Kulkarni G, Finelli A, Zlotta AR, Hamilton R, Gleave M, Fleshner NE. A Phase II, Randomized, Open-Label Study of Neoadjuvant Degarelix versus LHRH Agonist in Prostate Cancer Patients Prior to Radical Prostatectomy. Clin Cancer Res. 2017 Apr 15;23(8):1974-1980. doi: 10.1158/1078-0432.CCR-16-1790. Epub 2016 Oct 18.

  PMID: 27756786 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; bicalutamide; Gonadotropin-Releasing Hormone

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)

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: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 28, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: November 1, 2015
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

CA (2)