androgen deprivation therapy for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prostate Cancer+1 Moreandrogen deprivation therapy - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial will investigate the effects of degarelix on human prostate cancer cells.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

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

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
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT00079001) in the Zoledronic Acid + Androgen Deprivation Therapy ARM group. Side effects include: Fatigue with 62%, Myalgia with 54%, Creatinine increased with 25%, Nausea with 23%, Diarrhea with 20%.

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: Drug
Untreated patients degarelix injection occur at days and 7± 1.
Drug
Experimental Group · 1 Intervention: degarelix injection · Intervention Types: Drug
treated patients with androgen deprivation
Drug
Experimental Group · 1 Intervention: androgen deprivation therapy · Intervention Types: Drug
Untreated patients degarelix injection occur at days 14±1
Drug
Experimental Group · 1 Intervention: degarelix injection · Intervention Types: Drug
Treatment
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.