← Back to Search

Antiandrogen + Radiation +/- Docetaxel for Prostate Cancer

Phase 2 & 3
Waitlist Available
Led By Mark Hurwitz, MD
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 90 days prior to step 1 registration
Primary treatment with radical prostatectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time to death from any cause assessed up to 9.5 years
Awards & highlights

Study Summary

This trial is testing docetaxel in combination with antiandrogen therapy and radiation therapy versus antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery.

Who is the study for?
Men with prostate cancer removed by surgery, no lymph node involvement or distant metastases, and a Gleason score >=7. They must have had the surgery within the last year, not received certain prior treatments for prostate cancer, and meet specific health criteria like blood counts and liver function tests.Check my eligibility
What is being tested?
The trial is testing if adding docetaxel to antiandrogen therapy and radiation improves outcomes in post-surgery prostate cancer patients compared to just antiandrogen therapy and radiation. It's a randomized study meaning participants are put into groups by chance.See study design
What are the potential side effects?
Possible side effects include those from radiation (skin irritation, fatigue), antiandrogens (hot flashes, sexual dysfunction), and docetaxel (hair loss, nausea). Each treatment has its own set of potential side effects that can vary in severity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been mostly active and able to carry out all my pre-disease activities up to 90 days before registration.
Select...
I had surgery to remove my prostate gland.
Select...
I had surgery to remove my prostate gland.
Select...
My lymph nodes were tested and found to be cancer-free or were not tested.
Select...
My hemoglobin level is at least 10.0 g/dl without any medical help.
Select...
I've had a bone scan or similar test within the last 4 months to check for cancer spread.
Select...
My prostate cancer score is 7 or higher and my PSA level was above 0.2 ng/ml before starting hormone therapy.
Select...
My testosterone level was checked after prostate surgery but before starting hormone therapy.
Select...
I had surgery for prostate cancer less than a year ago.
Select...
I've had treatments for an enlarged prostate or HIFU before my prostate surgery.
Select...
I stopped hormone therapy for prostate cancer at least 90 days ago.
Select...
My lymph nodes were tested and found to be cancer-free or were not tested.
Select...
I've had a CT or MRI scan of my abdomen/pelvis in the last 120 days showing no major lymph node issues.
Select...
My prostate cancer score is 7 or higher and my PSA level was above 0.2 ng/ml before starting hormone therapy.
Select...
My hemoglobin level is at least 10.0 g/dl without any medical help.
Select...
I have had surgery to remove my prostate.
Select...
My cancer tissue sample is available for genetic testing.
Select...
My cancer tissue sample is available for genetic testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time to death from any cause assessed up to 9.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time to death from any cause assessed up to 9.5 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
Freedom from progression (FFP) (Phase II)
Metastasis free survival (MFS) (Phase III)
Secondary outcome measures
Overall survival
Proportion of undetectable PSA with a non-castrate testosterone
Proportions of patients with Grade 3 through Grade 5 adverse events that are either related to study drug or not graded according to NCI CTCAE version 3.0
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (androgen deprivation therapy, EBRT, docetaxel)Experimental Treatment8 Interventions
Patients receive androgen deprivation therapy and EBRT as in Arm I. Within 4-6 weeks after completion of radiation therapy, patients receive docetaxel IV on day 1 of every 21 days for 6 courses in the absence of disease progression or unexpected toxicity.
Group II: Arm I (androgen deprivation therapy, EBRT)Active Control7 Interventions
Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, bicalutamide, flutamide, or nilutamide for 6 months. Beginning 8 weeks after the start of androgen deprivation therapy, patients receive EBRT for 7.5 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bicalutamide
2003
Completed Phase 3
~5330
Docetaxel
1995
Completed Phase 4
~5620
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Flutamide
2013
Completed Phase 4
~1920
Goserelin Acetate
2007
Completed Phase 3
~1040
Leuprolide Acetate
2002
Completed Phase 3
~1890
Nilutamide
1996
Completed Phase 3
~310

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,649 Total Patients Enrolled
20 Trials studying Prostate Cancer
12,301 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,100 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,054 Patients Enrolled for Prostate Cancer
Mark Hurwitz, MDPrincipal InvestigatorNRG Oncology
3 Previous Clinical Trials
179 Total Patients Enrolled
2 Trials studying Prostate Cancer
143 Patients Enrolled for Prostate Cancer

Media Library

External Beam Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03070886 — Phase 2 & 3
Prostate Cancer Research Study Groups: Arm I (androgen deprivation therapy, EBRT), Arm II (androgen deprivation therapy, EBRT, docetaxel)
Prostate Cancer Clinical Trial 2023: External Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT03070886 — Phase 2 & 3
External Beam Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03070886 — Phase 2 & 3

Frequently Asked Questions

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

What conditions has Docetaxel been shown to be effective against?

"Docetaxel is primarily used to soothe skin conditions. However, it can also be used as treatment for metastatic bladder cancer, anger management therapy, and advance directives."

Answered by AI

How many different places is this research project being organized and executed?

"There are 103 locations for this clinical trial, with 3 sites being Aria Health-Torresdale Campus in Philadelphia, Pennsylvania, Kaiser Permanente-Oakland in Oakland, California and Mercy Hospital Saint Louis in Saint Louis, Missouri."

Answered by AI

How many volunteers are currently enrolled in this research?

"This study is not looking for volunteers at this time. The clinical trial was first posted on January 16th, 2017 and the last update was on September 7th, 2022. However, if you are interested in other trials, there are presently 2019 clinical trials actively recruiting participants with adenocarcinoma and 569 trials for Docetaxel admitting participants."

Answered by AI

What other treatments has Docetaxel been trialed against?

"As of now, 569 clinical trials are underway that focus on Docetaxel. Of those active studies, 197 have reached Phase 3 testing. Given the broad scope of this research, 30749 locations across the globe are running these types of trials."

Answered by AI
~39 spots leftby May 2026