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

Study Overview
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Brief Summary
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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.

Detailed Description
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This trial will include hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists but prior to use of secondary hormonal treatments such as antiandrogens. The purpose of this trial is to determine the effect of Degarelix's direct mode of action on androgen levels and whether continuous use of Degarelix improves disease progression. This is an open-label, multi-centre, Phase IV observational trial with s.c. injections of Degarelix one-month depot in patients with advanced prostate cancer. The visit frequency is once a month (28-day intervals), with eCRF data entry at every 4 months. All patients will be treated with a one-month starting dose followed by 23 monthly maintenance doses for a duration of 672 days. The primary endpoints will be evaluated after 24 treatment months. In total, 25 visits are scheduled for all patients.

Official Title
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Hormone Sensitive Prostate Cancer Patients Switched to Degarelix Therapy After Failing on GnRH Agonists: A Prospective, Observational, Phase IV Study (DELAY)

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate Cancer<br>Males who have been diagnosed with Prostate Cancer and are experiencing PSA rise, while taking androgen agonist therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testosterone Suppression | To evaluate testosterone supression in hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists | Two Years after first dose of degarelix. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormone Levels | 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 | Two Years after first dose of degarelix. | 
| PSA Response | To evaluate PSA response (ability of Degarelix to stabilise or reverse PSA progression) | Two Years after first dose of degarelix. | 
| PSA Failure | To evaluate how long patients are on degeralix prior to demonstrating biochemical disease progression (time to PSA failure) | Two Years after first dose of degarelix. | 
| PSA Doubling Time | To evaluate PSA doubling time. | Two Years after first dose of degarelix. | 
| Time to Metastases | To evaluate how long patients are on degeralix before they develop metastases (non-metastatic patients) | Two Years after first dose of degarelix. | 
| Time to Chemotherapy | Eevaluate how long patients have been on degeralix before initiating chemotherapy. | Two Years after first dose of degarelix. | 
| Time to Anti-Androgen use | Evaluate how long patients are on degeralix before initiating anti-androgen use as well as response to anti-androgen use | Two Years after first dose of degarelix. | 
| Patient Performance Status | To evaluate patient performance status as defined by the Eastern Cooperative Oncology Group (ECOG). | Two Years after first dose of degarelix. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Androgen Deprivation Therapy, Agonist, Antagonist, PSA Failure, PSA Rise