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Trial · Observational

CompletedPhase not statedRegistry data

Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists

Short name DELAY

NCTNCT01366053 (opens ClinicalTrials.gov in a new tab)Other idCMX-DELAY2010
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Degarelix, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase not stated
Enrollment
125 participants (actual)
Sponsor
CMX Research · Other
Design
Not stated
Countries
1 country

Canada

Start
Mar 2011
Primary completion
Jul 2015
Completion
Jul 2015
First posted
3 Jun 2011 (estimated)
Last update posted
22 Dec 2016 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013201420152016
  1. Ph –

    DELAY

    NCT01366053

    Mar 2011 to Jul 2015

Registry summary

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

This Phase IV observational trial is intended to identify patients who are failing GnRH agonist therapy as evidenced by a rising PSA and who have yet to initiate secondary manoeuvres involving antiandrogens. This group may include both non-metastatic as well as metastatic patients. The trial will determine if these patients will benefit from switching to Degarelix. It will assess the effect of Degarelix's direct mode of action on androgen levels and whether continuous use of Degarelix improves disease progression. As per the CUA Guidelines for the Management of CRPC, because the androgen receptor remains active in most patients who have developed castration resistant disease, it is recommended that ADT should be continued (LEVEL 3, GRADE C). Therefore, it is logical to continue patients on Degarelix throughout the castrate resistant period. This will allow for the gathering of data that is currently unknown within this setting, such as the effect of combined treatment with antiandrogens as well as chemotherapy and other castrate resistant treatments.

Arms1

  • Other

    Prostate Cancer

    Males who have been diagnosed with Prostate Cancer and are experiencing PSA rise, while taking androgen agonist therapy.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Testosterone Suppression

    Time frame · Two Years after first dose of degarelix.

    Registry description

    To evaluate testosterone supression in hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists

Secondary outcomes(8)

  1. Hormone Levels

    Time frame · Two Years after first dose of degarelix.

    Registry description

    To evaluate testosterone, bio available testosterone (calculated), prostate serum antigen (PSA), luteinizing hormone (LH) , follicle-stimulating hormone (FSH), dihydrotestosterone (DHT) and dehydroepiandrosterone (DHEA) before and after switching to Degarelix and over time

  2. PSA Response

    Time frame · Two Years after first dose of degarelix.

    Registry description

    To evaluate PSA response (ability of Degarelix to stabilise or reverse PSA progression)

  3. PSA Failure

    Time frame · Two Years after first dose of degarelix.

    Registry description

    To evaluate how long patients are on degeralix prior to demonstrating biochemical disease progression (time to PSA failure)

  4. PSA Doubling Time

    Time frame · Two Years after first dose of degarelix.

    Registry description

    To evaluate PSA doubling time.

  5. Time to Metastases

    Time frame · Two Years after first dose of degarelix.

    Registry description

    To evaluate how long patients are on degeralix before they develop metastases (non-metastatic patients)

  6. Time to Chemotherapy

    Time frame · Two Years after first dose of degarelix.

    Registry description

    Eevaluate how long patients have been on degeralix before initiating chemotherapy.

  7. Time to Anti-Androgen use

    Time frame · Two Years after first dose of degarelix.

    Registry description

    Evaluate how long patients are on degeralix before initiating anti-androgen use as well as response to anti-androgen use

  8. Patient Performance Status

    Time frame · Two Years after first dose of degarelix.

    Registry description

    To evaluate patient performance status as defined by the Eastern Cooperative Oncology Group (ECOG).

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

Studies6

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2008

7 results

Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker--results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer.

Van Poppel et al. 2008European urologycited by 91

PMID 18538469DOI 10.1016/j.eururo.2008.04.065PUB-18538469

Full text at the publisher7 results
Publisher pageSee results (7)

Indexing hint: Randomized controlled trial · 2008

7 results

A 1-year, open label, randomized phase II dose finding study of degarelix for the treatment of prostate cancer in North America.

Gittelman et al. 2008The Journal of urologycited by 67

PMID 18801505DOI 10.1016/j.juro.2008.07.033PUB-18801505

Full text at the publisher7 results
Publisher pageSee results (7)

Indexing hint: Randomized controlled trial · 2004

7 results

Similar frequency of testosterone surge after repeat injections of goserelin (Zoladex) 3.6 mg and 10.8 mg: results of a randomized open-label trial.

Zinner et al. 2004Urologycited by 40

PMID 15596193DOI 10.1016/j.urology.2004.07.033PUB-15596193

Full text at the publisher7 results
Publisher pageSee results (7)

More studies

3 studies on this page

Indexing hint: Clinical trial · 2003

3-month formulation of goserelin acetate ('Zoladex' 10.8-mg depot) in advanced prostate cancer: results from an Italian, open, multicenter trial.

Fontana et al. 2003Urologia internationaliscited by 23

PMID 12740498DOI 10.1159/000070142PUB-12740498

Full text at the publisher
Publisher page

Indexing hint: Clinical trial · 1998

An evaluation of pharmacokinetics and pharmacodynamics of leuprorelin acetate 3M-depot in patients with advanced and metastatic carcinoma of the prostate.

Khan et al. 1998Urologia internationaliscited by 32

PMID 9519419DOI 10.1159/000030200PUB-09519419

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 1998

Leuprorelin three-month depot in the treatment of advanced and metastatic prostate cancer: long-term follow-up results.

Jocham et al. 1998Urologia internationaliscited by 18

PMID 9607554DOI 10.1159/000056547PUB-09607554

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Able to read and write, understand instructions related to trial procedures and give written informed consent before any trial-related activity is performed * Histologically confirmed adenocarcinoma of the prostate (prostate cancer) * Currently under hormonal management of prostate cancer with a GnRH agonist * Confirmed biochemical PSA progression on GnRH agonist therapy, defined as ≥50% increase in PSA between 2 measurements, taken at least 1 week apart * PSA ≥1.0 ng/ml * ECOG score ≤2 * Able and willing to participate in the full duration of the clinical trial * Male patient aged 18 years or older * Life expectancy of at least 12 months Exclusion Criteria: * Prior treatment with chemotherapy, radiopharmaceuticals, estrogen, ketoconazole or other secondary hormonal treatments such as antiandrogens except for induction phase (\<3 months) * History of dermatitis, lupus, eczema, psoriasis affecting area used for Degarelix injections * Allergy to Degarelix or its components * Has a 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 * Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy. * Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema * Has a mental incapacity or language barrier precluding adequate understanding or co operation

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