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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years post-randomization
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I have a history of blood clots but am considered fit for prostate surgery.
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My cancer is confirmed as prostate adenocarcinoma.
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My prostate cancer is aggressive, with a high Gleason score or a low chance of being progression-free in 5 years.
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I have prostate cancer and haven't had surgery, radiation, or chemo, but may have had up to 4 months of hormone therapy.
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My prostate cancer's aggressiveness has been measured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Biochemical Progression-Free Survival (bPFS Proportion) at 3 Years
Secondary outcome measures
5-year bPFS Rate
Disease Progression
Overall Survival (The Date of Randomization to the Time of Death Due to Prostate Cancer.)
+4 more

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
~6010

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupNETWORK
388 Previous Clinical Trials
261,463 Total Patients Enrolled
26 Trials studying Prostate Cancer
52,762 Patients Enrolled for Prostate Cancer
SWOG Cancer Research NetworkNETWORK
394 Previous Clinical Trials
264,822 Total Patients Enrolled
26 Trials studying Prostate Cancer
52,762 Patients Enrolled for Prostate Cancer
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
216,846 Total Patients Enrolled
29 Trials studying Prostate Cancer
5,136 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different geographical areas is this trial taking place?

"Currently, this trial is enrolling at 100 sites. The locations are based in Billings, Jackson and Robbinsdale as well as 100 other locations. If you choose to participate, it is important to select the location closest you to minimize travel demands."

Answered by AI

Are there any current vacancies for participants in this research?

"The latest information from clinicaltrials.gov is that this study has completed recruiting patients for the trial. The trial was posted on May 8th, 2007 and last edited January 10th, 2020. Even though this specific study isn't looking for more participants, there are 1,790 other trials going on right now that are actively enrolling patients."

Answered by AI

Are there any life-threatening dangers associated with docetaxel?

"Docetaxel is considered safe by our team at Power, who gave it a score of 3. This is due to the fact that docetaxel is currently in Phase 3 trials, meaning there is preliminary evidence of its efficacy as well as multiple rounds of data affirming its safety."

Answered by AI

What are the most common illnesses that docetaxel is prescribed for?

"Docetaxel is most commonly used as an anti-cancer medication, but can also be effective in treating stage t2b carcinoma of the prostate, sarcoma, and other conditions."

Answered by AI

How many test subjects are involved in this experiment?

"While this study is no longer recruiting, it's worth noting that there are currently 1364 trials for patients with prostate cancer and 426 trials for docetaxel."

Answered by AI

How effective has docetaxel been in other medical trials?

"426 clinical trials are currently being conducted for docetaxel. Of those, 163 have progressed to Phase 3 testing. 29427 locations around the world are running studies on this cancer treatment medication, with most of the research teams based out of Duarte, California."

Answered by AI
~44 spots leftby Mar 2025