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Trial · Interventional

WithdrawnPhase 2Registry data

Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)

Overview

Status
Withdrawn
Phase
Phase 2
Enrollment
0 participants (actual)
Sponsor
British Columbia Cancer Agency · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Canada

Start
Aug 2012 (estimated)
Primary completion
Dec 2013 (estimated)
Completion
Dec 2013 (estimated)
First posted
28 Jun 2012 (estimated)
Last update posted
1 Oct 2026
Conditions
Prostate Neoplasm

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 2

    Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)

    NCT01630967

    est. Aug 2012 to est. Dec 2013

    Withdrawn

Registry summary

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

Men with castrate resistant prostate cancer who are switched from a luteinizing hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in prostate-specific antigen (PSA).

Interventions

  • DegarelixDrug

Arms1

  • Experimental

    Degarelix

    Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 50% fall in PSA

    Time frame · 8 weekly

    Registry description

    Proportion of patients with castrate resistant prostate cancer (CRPC) who have a PSA decline of ≥50% from baseline when switched from an LHRH agonist to an LHRH antagonist

Secondary outcomes(7)
  1. Luteinizing hormone (LH)

    Time frame · 8 weekly

    Registry description

    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

  2. Follicle stimulating hormone (FSH)

    Time frame · 8 weekly

    Registry description

    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

  3. Testosterone (TT)

    Time frame · 8 weekly

    Registry description

    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

  4. dehydroepiandrosterone (DHEA)

    Time frame · 8 weekly

    Registry description

    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

  5. dehydroepiandrosterone-sulfate (DHEA-S)

    Time frame · 8 weekly

    Registry description

    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

  6. androstenedione (AED)

    Time frame · 8 weekly

    Registry description

    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

  7. dihydrotestosterone (DHT)

    Time frame · 8 weekly

    Registry description

    Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).

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.

A trial that is still running, or that stopped early, may post results later.

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 · 2011

7 results

A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer.

Crawford et al. 2011The Journal of urologycited by 102

PMID 21788033DOI 10.1016/j.juro.2011.04.083PUB-21788033

Full text at the publisher7 results

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * histologically confirmed adenocarcinoma of the prostate * currently receiving LHRH agonist * Anti-androgen oral therapy is permitted but will be discontinued upon enrollment * PSA \> 2 ng/ml * rising PSA despite LHRH agonist * patients may or may not have clinical evidence off metastases. If metastases are present, they must be asymptomatic and in bone or lymph node only * Prior chemotherapy allowed * ECOG performance status 0-1 Exclusion Criteria: * Patients with a history of other active malignancies, except: adequately treated non-melanoma skin cancer, superficial bladder cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years. * Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including: i)Significant cardiovascular condition including but not limited to: uncontrolled hypertension, unstable angina, significant congestive heart failure or myocardial infarction, deep venous thrombosis, pulmonary embolus or cerebrovascular attack within the last 6 months. ii) History of significant neurological disorder that would impair the ability to obtain consent

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