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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 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 • NCT00079001
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%
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%
Insomnia
2%
Urinary retention
2%
Leukocyte count decreased
2%
Myocardial ischemia
2%
Constipation
2%
Serum sodium decreased
2%
Arthralgia
2%
Dyspnea
2%
Renal failure
1%
Disease progression
1%
Infection
1%
Serum albumin decreased
1%
Bladder infection
1%
Ureteric obstruction
1%
Laboratory test abnormal
1%
Pneumonia
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
1,933 Previous Clinical Trials
585,579 Total Patients Enrolled
132 Trials studying Prostate Cancer
52,033 Patients Enrolled for Prostate Cancer
Ferring PharmaceuticalsIndustry Sponsor
313 Previous Clinical Trials
440,817 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

Degarelix (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01542021 — N/A
Prostate Cancer Research Study Groups: Untreated patients degarelix injection occur at days 4± 1, Untreated patients degarelix injection occur at days and 7± 1., treated patients with androgen deprivation, Untreated patients degarelix injection occur at days 14±1
Prostate Cancer Clinical Trial 2023: Degarelix Highlights & Side Effects. Trial Name: NCT01542021 — N/A
Degarelix (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01542021 — N/A

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
~2 spots leftby Feb 2025