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Hormone Therapy
Androgen Deprivation Therapy for Prostate Cancer
N/A
Waitlist Available
Led By Dana Rathkopf, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will investigate the effects of degarelix on human prostate cancer cells.
Who is the study for?
This trial is for men with intermediate or high-risk prostate cancer who are planning to have their prostate removed. They must not have had chemotherapy, radiation therapy, or certain hormonal therapies before. Participants need a specific level of testosterone and agree to use contraception during the study and for 3 months after.Check my eligibility
What is being tested?
The trial is testing if giving degarelix, a drug that lowers testosterone levels, before surgery can affect prostate cancer cells in a beneficial way. Although no direct benefit from degarelix is expected since the prostate will be removed, researchers aim to gather information for future treatments.See study design
What are the potential side effects?
Degarelix may cause side effects such as hot flashes, injection site reactions (like pain or swelling), increased weight, tiredness and changes in liver function tests. It might also affect heart rhythm and bone density over longer-term use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
Secondary outcome measures
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
Side effects data
From 2014 Phase 3 trial • 645 Patients • NCT0007900162%
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%
Rash desquamating
12%
Serum phosphate decreased
7%
Serum magnesium decreased
7%
Pruritus
6%
Bone pain
5%
Back pain
5%
Alkaline phosphatase increased
4%
Blood glucose increased
3%
Erectile dysfunction
3%
Hypersensitivity
3%
Hemoglobin decreased
3%
Osteonecrosis
2%
Urinary retention
2%
Insomnia
2%
Leukocyte count decreased
2%
Myocardial ischemia
2%
Constipation
2%
Serum sodium decreased
2%
Arthralgia
2%
Dyspnea
2%
Renal failure
1%
Laboratory test abnormal
1%
Disease progression
1%
Infection
1%
Serum albumin decreased
1%
Bladder infection
1%
Pneumonia
1%
Ureteric obstruction
1%
Dehydration
1%
Peripheral motor neuropathy
1%
Musculoskeletal disorder
1%
Skin infection
1%
Pain
1%
Muscle weakness
1%
Alanine aminotransferase increased
1%
Cardiac disorder
1%
Abdominal pain
1%
Lower gastrointestinal hemorrhage
1%
Small intestinal obstruction
1%
Sudden death
1%
Urinary tract infection
1%
Fracture
1%
Lymphocyte count decreased
1%
Neutrophil count decreased
1%
Dizziness
1%
Syncope vasovagal
1%
Hemolysis
1%
Cataract
1%
Pain in extremity
1%
Treatment related secondary malignancy
1%
Dysgeusia
1%
Headache
1%
Urinary frequency
1%
Testicular pain
1%
Cough
1%
Hot flashes
1%
Hypertension
1%
Serum magnesium increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zoledronic Acid + Androgen Deprivation Therapy
Placebo + Androgen Deprivation Therapy
Trial Design
4Treatment groups
Experimental Treatment
Group I: treated patients with androgen deprivationExperimental Treatment1 Intervention
Patients already treated with androgen deprivation are assigned to Cohort 3 and maintained on current androgen deprivation therapy until they undergo or have already undergone RP at MSKCC. Will include patients who have already undergone hormonal therapy (of any duration between 1 and 6 months) prior to prostatectomy.
Group II: Untreated patients degarelix injection occur at days and 7± 1.Experimental Treatment1 Intervention
Treatment will consist of a single 240 mg injection of degarelix 7±1 day before radical prostatectomy
Group III: Untreated patients degarelix injection occur at days 4± 1Experimental Treatment1 Intervention
Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy
Group IV: Untreated patients degarelix injection occur at days 14±1Experimental Treatment1 Intervention
Treatment will consist of a single 240 mg injection of degarelix 14±1 day before radical prostatectomy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
androgen deprivation therapy
2004
Completed Phase 3
~650
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,841 Total Patients Enrolled
132 Trials studying Prostate Cancer
52,041 Patients Enrolled for Prostate Cancer
Ferring PharmaceuticalsIndustry Sponsor
314 Previous Clinical Trials
440,842 Total Patients Enrolled
51 Trials studying Prostate Cancer
17,826 Patients Enrolled for Prostate Cancer
Dana Rathkopf, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
123 Total Patients Enrolled
3 Trials studying Prostate Cancer
86 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My biopsy shows at least 2 samples with cancer longer than 3mm.My prostate cancer is aggressive (Gleason score 7 or higher).I have had blood clots or a stroke but am considered fit for surgery.I am planning to have or have had a major prostate surgery at MSKCC.My prostate cancer diagnosis was confirmed with a biopsy showing 3 or more positive cores.I have enough biopsy tissue available for analysis.You cannot take any other experimental drugs while participating in this study.My cancer is not adenocarcinoma but another type.I stopped taking dutasteride at least 4 weeks before my treatment or surgery.I have undergone chemotherapy.I have taken saw palmetto for my cancer within a week of receiving degarelix or before surgery.I have received radiation therapy for prostate cancer.I do not have any ongoing infections or illnesses.I have not used hormonal therapies like antiandrogens for my condition.I agree to use contraception during and for 3 months after the study.My testosterone level is above 100 ng/dL.I have been on hormone therapy for prostate cancer for 1-6 months before surgery.I am mostly independent and can care for myself.
Research Study Groups:
This trial has the following groups:- Group 1: Untreated patients degarelix injection occur at days 4± 1
- Group 2: Untreated patients degarelix injection occur at days and 7± 1.
- Group 3: treated patients with androgen deprivation
- Group 4: Untreated patients degarelix injection occur at days 14±1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elucidate other investigations that have explored androgen deprivation therapy?
"At the moment, 31 medical trials are actively investigating androgen deprivation therapy. Of those31 studies, 8 are in their final phase of clinical trial testing. While mostly centred around Los Angeles, 1481 other locations across the nation have ongoing research for this treatment."
Answered by AI
Is this research unprecedented in its field?
"Since 2012, experiments into androgen deprivation therapy have been ongoing. The original research was backed by Ferring Pharmaceuticals in 2012 and completed with 41 participants; after that successful trial it received the necessary approval for medicinal use. Presently, 31 live trials are scattered across 563 cities within 14 countries."
Answered by AI
Are there any slots left to participate in this experiment?
"According to clinicaltrials.gov, this trial is not accepting participants at the moment. This experiment was initially listed on February 1st 2012 and last updated on February 28th 2022. However, there are over 1300 other trials currently recruiting volunteers in various locations throughout the world."
Answered by AI
What is the current enrollment capacity for this research endeavor?
"This investigation has reached its recruitment limit for now; the initial post date was February 1st 2012, and it has been revised as recently as 28th of February 2022. Notwithstanding, there are currently 1321 trials that involve persons with prostate cancer searching for subjects and 31 experiments concerning Androgen Deprivation Therapy looking to enroll participants."
Answered by AI
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