Prostate Cancer
Conditions
Keywords
Prostate Cancer, Androgen Deprivation Therapy, Agonist, Antagonist, PSA Failure, PSA Rise
Brief summary
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
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.
Interventions
None listed
Sponsors
Ferring Pharmaceuticals
CMX Research
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Testosterone Suppression | Two Years after first dose of degarelix. | To evaluate testosterone supression in hormone sensitive prostate cancer patients switched to Degarelix therapy after failing on GnRH agonists |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSA Response | Two Years after first dose of degarelix. | To evaluate PSA response (ability of Degarelix to stabilise or reverse PSA progression) |
| PSA Failure | Two Years after first dose of degarelix. | To evaluate how long patients are on degeralix prior to demonstrating biochemical disease progression (time to PSA failure) |
| PSA Doubling Time | Two Years after first dose of degarelix. | To evaluate PSA doubling time. |
| Hormone Levels | Two Years after first dose of degarelix. | 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 |
| Time to Chemotherapy | Two Years after first dose of degarelix. | Eevaluate how long patients have been on degeralix before initiating chemotherapy. |
| Time to Anti-Androgen use | Two Years after first dose of degarelix. | Evaluate how long patients are on degeralix before initiating anti-androgen use as well as response to anti-androgen use |
| Patient Performance Status | Two Years after first dose of degarelix. | To evaluate patient performance status as defined by the Eastern Cooperative Oncology Group (ECOG). |
| Time to Metastases | Two Years after first dose of degarelix. | To evaluate how long patients are on degeralix before they develop metastases (non-metastatic patients) |
Countries
Canada
Outcome results
None listed