Prostate Neoplasm
Conditions
Keywords
castrate resistance, PSA progression, LHRH antagonism
Brief summary
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).
Detailed description
To determine the proportion of patients with castrate resistant Prostate Cancer who have a PSA decline of ≥50% from baseline PSA when switched from an LHRH agonist to an LHRH antagonist.
Interventions
DRUGDegarelix
Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.
Sponsors
Ferring Pharmaceuticals
British Columbia Cancer Agency
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 50% fall in PSA | 8 weekly | 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
| Measure | Time frame | Description |
|---|---|---|
| Follicle stimulating hormone (FSH) | 8 weekly | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
| Testosterone (TT) | 8 weekly | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
| dehydroepiandrosterone (DHEA) | 8 weekly | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
| Luteinizing hormone (LH) | 8 weekly | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
| androstenedione (AED) | 8 weekly | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
| dihydrotestosterone (DHT) | 8 weekly | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
| dehydroepiandrosterone-sulfate (DHEA-S) | 8 weekly | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
Countries
Canada
Contacts
Primary ContactKim N Chi, MD
Outcome results
None listed