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Chemotherapy + Hormone Therapy With Surgery for Prostate Cancer

Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: ≥ 18 years of age
ECOG performance status: 0-2
Must not have
History of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation and not determined to be candidates for radical prostatectomy
Active malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial is comparing docetaxel given before surgery to surgery alone in treating patients with high-risk localized prostate cancer to see if it is more effective.

Who is the study for?
This trial is for men with high-risk localized prostate cancer who are fit for surgery and expected to live more than 10 years. They must have a specific type of prostate cancer (adenocarcinoma), no prior treatments except possibly short-term hormone therapy, and no evidence of spread beyond the prostate. Men with other recent cancers or certain blood clotting events not suitable for surgery can't join.
What is being tested?
The study is testing if giving chemotherapy drug docetaxel along with hormone therapies leuprolide or goserelin before surgery offers better outcomes compared to just having the surgery alone. The goal is to see if this combination treatment can shrink tumors more effectively, making them easier to remove surgically.
What are the potential side effects?
Docetaxel may cause side effects like fatigue, hair loss, nail changes, nausea, and numbness in fingers or toes. Hormone therapies like leuprolide or goserelin might lead to hot flashes, sexual dysfunction, bone thinning, mood swings, and injection site pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am able to get out of my bed or chair and move around.
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My cancer is in an early stage and has not spread, as confirmed by scans.
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I am a good candidate for prostate surgery and expected to live more than 10 years.
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My cancer is confirmed as prostate adenocarcinoma.
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My prostate cancer's aggressiveness has been measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of blood clots or stroke and cannot undergo major prostate surgery.
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I currently have cancer.
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My cancer is not small cell, neuroendocrine, or transitional cell carcinoma.
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I need assistance with my daily activities due to my health condition.
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I am under 18 years old.
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I have had a condition where my lymphocytes multiply unusually.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Biochemical Progression-Free Survival (bPFS Proportion) at 3 Years
Secondary study objectives
5-year bPFS Rate

Side effects data

From 2012 Phase 3 trial • 5351 Patients • NCT00003782
22%
Febrile neutropenia
12%
Fatigue
11%
Infections and infestations - Other, specify
9%
Nausea
8%
Myalgia
8%
Vomiting
7%
Arthralgia
4%
Diarrhea
1%
Hyperglycemia
1%
Thromboembolic event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Doxorubicin + Cyclophosphamide, Then Docetaxel
Doxorubicin + Docetaxel
Doxorubicin + Docetaxel + Cyclophosphamide

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: surgical interventionExperimental Treatment1 Intervention
All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery.
Group II: Arm A: docetaxel + LHRH agonist + surgical interventionExperimental Treatment3 Interventions
Patients receive six cycles of docetaxel administered every 3 weeks combined with 18-24 weeks of androgen deprivation therapy. During each cycle of chemotherapy, all patients should undergo premedication with dexamethasone 8 mg orally prior to docetaxel. Dexamethasone may also be given intravenously according to institutional guidelines. Patients will also receive androgen deprivation for 18-24 weeks of an LHRH agonist (eg, leuprolide acetate, goserelin acetate). Additional premedication and antiemetics may be given at the physician's discretion and as defined by the protocol. Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved
Goserelin
FDA approved
surgery
2005
Completed Phase 4
~7020

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupNETWORK
388 Previous Clinical Trials
260,399 Total Patients Enrolled
26 Trials studying Prostate Cancer
52,762 Patients Enrolled for Prostate Cancer
Eastern Cooperative Oncology GroupNETWORK
268 Previous Clinical Trials
150,807 Total Patients Enrolled
23 Trials studying Prostate Cancer
48,380 Patients Enrolled for Prostate Cancer
SWOG Cancer Research NetworkNETWORK
396 Previous Clinical Trials
264,664 Total Patients Enrolled
26 Trials studying Prostate Cancer
52,762 Patients Enrolled for Prostate Cancer

Media Library

Surgery Clinical Trial Eligibility Overview. Trial Name: NCT00430183 — Phase 3
Prostate Cancer Research Study Groups: Arm A: docetaxel + LHRH agonist + surgical intervention, Arm B: surgical intervention
Prostate Cancer Clinical Trial 2023: Surgery Highlights & Side Effects. Trial Name: NCT00430183 — Phase 3
Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT00430183 — Phase 3
~43 spots leftby Oct 2025
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