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Hormone Therapy

Docetaxel for Prostate Cancer

Phase < 1
Waitlist Available
Led By Christos Kyriakopoulos, MD
Research Sponsored by University of Wisconsin, Madison
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 from baseline (3 months prior to prostatectomy) to 4-6 weeks after prostatectomy.
Awards & highlights

Study Summary

This trial is testing a new combination treatment for prostate cancer that includes androgen deprivation therapy, docetaxel chemotherapy, and radical prostatectomy. The study will evaluate the effectiveness of the treatment and its side effects.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (3 months prior to prostatectomy) to 4-6 weeks after prostatectomy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (3 months prior to prostatectomy) to 4-6 weeks after prostatectomy. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in pCR rates
Secondary outcome measures
Change in PSA
PSA Recurrence
Safety and tolerability of combination ADT and docetaxel measured by CTCAE v.4.0
Other outcome measures
Change in total tumor burden in individual lesions
Disease progression
Disseminated and circulating tumor cell analyses versus PSMA PET/MRI and clinical outcomes
+12 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: DegarelixSC + bicalutamide + docetaxel + Ferumoxytol enhanced MRIExperimental Treatment4 Interventions
Degarelix SC monthly x3 + bicalutamide 50mg orally QD x 14 wks + Docetaxel 75mg/m2 IV q 21 days x 3 + Ferumoxytol enhanced MRI within 21 days prior to start of hormonal therapy and second and final ferumoxytol-enhanced MRI at the conclusion of hormone therapy but prior to their prostatectomy.
Group II: Degarelix SC + bicalutamide + docetaxelExperimental Treatment3 Interventions
Degarelix SC monthly x3 + bicalutamide 50mg orally QD x 14 wks + Docetaxel 75mg/m2 IV q 21 days x 3
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bicalutamide
2003
Completed Phase 3
~5330
Degarelix
2002
Completed Phase 3
~3600
Docetaxel
1995
Completed Phase 4
~5620
Ferumoxytol-enhanced MRI imaging
2018
Completed Early Phase 1
~30

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
865 Previous Clinical Trials
327,669 Total Patients Enrolled
38 Trials studying Prostate Cancer
9,174 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,750 Total Patients Enrolled
27 Trials studying Prostate Cancer
1,900 Patients Enrolled for Prostate Cancer
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,516 Total Patients Enrolled
33 Trials studying Prostate Cancer
8,936 Patients Enrolled for Prostate Cancer

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
Pilot Trial of Chemohormonal Therapy Followed by Prostatectomy in High Risk Prostate Cancer
2018. "Pilot Trial of Chemohormonal Therapy Followed by Prostatectomy in High Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03358563.
~4 spots leftby Apr 2025
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