Skip to content

Trial · Interventional

CompletedPhase 2Registry data

Degarelix Neo-Adjuvant Radical Prostatectomy Trial

NCTNCT01674270 (opens ClinicalTrials.gov in a new tab)Other idDEG_PRE-OP_001Other idDegarelix Pre-Op

Overview

Status
Completed
Phase
Phase 2
Enrollment
35 participants (actual)
Sponsor
University Health Network, Toronto · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Canada

Start
Aug 2012
Primary completion
Dec 2014
Completion
Nov 2015
First posted
28 Aug 2012 (estimated)
Last update posted
22 Dec 2015 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122013201420152016
  1. Ph 2

    Degarelix Neo-Adjuvant Radical Prostatectomy Trial

    NCT01674270

    Aug 2012 to Nov 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • DegarelixDrug
  • CasodexDrug
  • LHRH AgonistDrug

Arms3

  • Experimental

    Degarelix

    Degarelix Alone

  • Experimental

    Degarelix + Casodex

    Degarelix and Casodex

  • Active comparator

    LHRH Agonist + Casodex

    LHRH Agonist and Casodex

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Intratumoral androgen levels

    Time frame · Week 12

Secondary outcomes(1)
  1. Prostate tumour morphology related to androgen withdrawal after neo-adjuvant therapy

    Time frame · Week 12

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

8 results

A Phase II, Randomized, Open-Label Study of Neoadjuvant Degarelix versus LHRH Agonist in Prostate Cancer Patients Prior to Radical Prostatectomy.

Sayyid et al. 2017Clinical cancer research : an official journal of the American Association for Cancer Researchcited by 31

PMID 27756786DOI 10.1158/1078-0432.ccr-16-1790PUB-27756786

Full text at the publisher8 results

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedZengerling 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

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

PepBank is a research reference. Talk to a doctor before you use any peptide.