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Antiandrogen

enzalutamide for Prostate Cancer

Phase 2
Waitlist Available
Led By Ulka Vaishampayan
Research Sponsored by Barbara Ann Karmanos Cancer Institute
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 assessed up to 6 years.
Awards & highlights

Study Summary

This trial is studying if adding enzalutamide to standard hormone therapy will improve treatment of prostate cancer compared to the standard therapy with a different drug.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 6 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 6 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
Number of Participants With PSA Remission Assessed Using the Prostate Cancer Clinical Trials Working Group (PCWG2) Criteria
Secondary outcome measures
Achievement of Measurable Disease Response
Achievement of PSA Response Assessed Using PCWG2 Criteria
Overall Survival at 2 Years
+6 more
Other outcome measures
Expression levels of the selected biomarkers
Length of CAG repeats

Side effects data

From 2021 Phase 4 trial • 255 Patients • NCT02485691
40%
Diarrhoea
30%
Anaemia
29%
Fatigue
26%
Asthenia
23%
Nausea
22%
Neutropenia
16%
Back Pain
15%
Constipation
14%
Haematuria
13%
Decreased Appetite
13%
Vomiting
12%
Dysgeusia
8%
Urinary Tract Infection
8%
Arthralgia
8%
Oedema Peripheral
8%
Abdominal Pain
8%
Stomatitis
7%
Cancer Pain
6%
Pain
6%
Leukopenia
6%
Alopecia
6%
Polyneuropathy
6%
Dyspnoea
6%
Pyrexia
6%
Neuropathy Peripheral
5%
Pain In Extremity
4%
Hypokalaemia
4%
Weight Decreased
4%
Hypertension
3%
Disease Progression
3%
Bone Pain
3%
Febrile Neutropenia
3%
Spinal Cord Compression
3%
Pneumonia
2%
Atrial Fibrillation
2%
Acute Kidney Injury
2%
Sepsis
1%
Atrial Flutter
1%
Vertigo
1%
Rectal Haemorrhage
1%
Spinal Pain
1%
Aspiration
1%
Flank Pain
1%
Transient Ischaemic Attack
1%
Urinary Retention
1%
General Physical Health Deterioration
1%
Inflammation
1%
Femoral Neck Fracture
1%
Oncologic Complication
1%
Gastroenteritis
1%
Pathological Fracture
1%
Neutropenic Infection
1%
Loss Of Consciousness
1%
Gamma-Glutamyltransferase Increased
1%
Tumour Pain
1%
Platelet Count Decreased
1%
Hydronephrosis
1%
Diarrhoea Haemorrhagic
1%
Malaise
1%
Hepatitis
1%
Toxicity To Various Agents
1%
Alanine Aminotransferase Increased
1%
Pancytopenia
1%
Neuroendocrine Carcinoma Of The Skin
1%
Carotid Artery Stenosis
1%
Syncope
1%
Haemoptysis
1%
Septic Shock
1%
Device Related Sepsis
1%
Laryngeal Inflammation
1%
Perineal Cellulitis
1%
Urosepsis
1%
Head Injury
1%
Cognitive Disorder
1%
Aspartate Aminotransferase Increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabazitaxel
Enzalutamide or Abiraterone

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (enzalutamide and LHRH analogue therapy)Experimental Treatment5 Interventions
Patients receive enzalutamide orally PO QD and undergo orchiectomy or receive LHRH analogue therapy (leuprolide acetate, goserelin acetate, or any other FDA approved preparation). Treatment continues in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (bicalutamide and LHRH analogue therapy)Active Control5 Interventions
Patients receive bicalutamide PO QD and undergo orchiectomy or receive LHRH analogue therapy as in Arm A. Treatment continues in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
orchiectomy
2004
Completed Phase 3
~900
Leuprolide
FDA approved
Enzalutamide
FDA approved
Goserelin
FDA approved

Find a Location

Who is running the clinical trial?

Barbara Ann Karmanos Cancer InstituteLead Sponsor
163 Previous Clinical Trials
9,215 Total Patients Enrolled
15 Trials studying Prostate Cancer
1,071 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,648 Previous Clinical Trials
40,931,612 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Ulka VaishampayanPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute
5 Previous Clinical Trials
127 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Hormone Sensitive Prostate Cancer
Elisabeth Heath 2014. "LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Hormone Sensitive Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02058706.
~7 spots leftby Apr 2025
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