Study Summary
This trial will investigate the effects of degarelix on human prostate cancer cells.
Eligible Conditions
- Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 2 years
2 years
To assess between the time to determine the time of the maximal change in prostate cancer cell proliferation (Ki-67) and apoptosis rates (cleaved caspase-3)
To discover novel biomarkers and correlates of response
To explore the association between PI3K pathway (pAKT and pS6) and prostate cancer proliferation and apoptosis rates after treatment with androgen deprivation therapy in relation to other markers of prostate cancer (ERG, AR and NCOA2).
To explore the association between PTEN status and maximal changes in prostate cancer proliferation and apoptosis rates in patients treated with androgen deprivation therapy
Trial Safety
Safety Progress
Side Effects for
Zoledronic Acid + Androgen Deprivation Therapy
62%Fatigue
54%Myalgia
25%Creatinine increased
23%Nausea
20%Diarrhea
19%Serum calcium decreased
17%Anorexia
14%Serum potassium decreased
14%Fever
13%Vomiting
12%Chills
12%Serum phosphate decreased
12%Rash desquamating
7%Pruritus
7%Serum magnesium decreased
6%Bone pain
5%Back pain
5%Alkaline phosphatase increased
4%Blood glucose increased
3%Hemoglobin decreased
3%Hypersensitivity
3%Erectile dysfunction
3%Osteonecrosis
2%Renal failure
2%Urinary retention
2%Serum sodium decreased
2%Constipation
2%Myocardial ischemia
2%Leukocyte count decreased
2%Dyspnea
2%Arthralgia
2%Insomnia
1%Treatment related secondary malignancy
1%Hypertension
1%Fracture
1%Laboratory test abnormal
1%Musculoskeletal disorder
1%Syncope vasovagal
1%Serum albumin decreased
1%Urinary frequency
1%Testicular pain
1%Neutrophil count decreased
1%Dizziness
1%Ureteric obstruction
1%Peripheral motor neuropathy
1%Pain
1%Muscle weakness
1%Dehydration
1%Small intestinal obstruction
1%Lymphocyte count decreased
1%Headache
1%Dysgeusia
1%Cough
1%Hot flashes
1%Cardiac disorder
1%Abdominal pain
1%Disease progression
1%Sudden death
1%Bladder infection
1%Urinary tract infection
1%Cataract
1%Infection
1%Pneumonia
1%Serum magnesium increased
1%Pain in extremity
1%Lower gastrointestinal hemorrhage
1%Hemolysis
1%Alanine aminotransferase increased
1%Skin infection
Trial Design
4 Treatment Groups
Untreated patients degarelix injection occur at days 4± 1
1 of 4
Untreated patients degarelix injection occur at days and 7± 1.
1 of 4
treated patients with androgen deprivation
1 of 4
Untreated patients degarelix injection occur at days 14±1
1 of 4
Experimental Treatment
41 Total Participants · 4 Treatment Groups
Primary Treatment: androgen deprivation therapy · No Placebo Group · N/A
Untreated patients degarelix injection occur at days 4± 1
Drug
Experimental Group · 1 Intervention: degarelix injection · Intervention Types: DrugUntreated patients degarelix injection occur at days and 7± 1.
Drug
Experimental Group · 1 Intervention: degarelix injection · Intervention Types: Drugtreated patients with androgen deprivation
Drug
Experimental Group · 1 Intervention: androgen deprivation therapy · Intervention Types: DrugUntreated patients degarelix injection occur at days 14±1
Drug
Experimental Group · 1 Intervention: degarelix injection · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
androgen deprivation therapy
2004
Completed Phase 3
~650
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,497 Total Patients Enrolled
127 Trials studying Prostate Cancer
65,374 Patients Enrolled for Prostate Cancer
Ferring PharmaceuticalsIndustry Sponsor
301 Previous Clinical Trials
438,503 Total Patients Enrolled
51 Trials studying Prostate Cancer
18,131 Patients Enrolled for Prostate Cancer
Dana Rathkopf, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
102 Total Patients Enrolled
2 Trials studying Prostate Cancer
49 Patients Enrolled for Prostate Cancer
Eligibility Criteria
Age 18+ · Male Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have 3 or more positive biopsy cores or equivalent tumor specimen as confirmed by pathologist.
The tumor must be a transitional cell carcinoma of the bladder or a TURP specimen is required for analysis.
You are planning to have or have had a radical prostatectomy (RP) at MSKCC.
You have a core containing at least 3 mm of tissue with carcinoma or equivalent tumor specimen as confirmed by pathologist.
The primary tumor must be Gleason score ≥ 7.
Candidates must have a history of deep vein thrombosis, pulmonary embolism, or cerebrovascular accident, or require concomitant systemic anticoagulation, if otherwise deemed to be suitable for RP.
For cohorts 1,2 and 4 only: non-castrate testosterone level > 100 ng/dL.
References
- Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blümle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8:CD012548. doi: 10.1002/14651858.CD012548.pub2. Review.
- Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
- 2012. "Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01542021.
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Conditions
Cancer Related
Treatments