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Antiandrogen + Radiation +/- Docetaxel for Prostate Cancer

Phase 2 & 3
Waitlist Available
Led By Mark D Hurwitz
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary treatment with radical prostatectomy
Pathologically proven to be lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [pNx])
Must not have
History of inflammatory bowel disease
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of randomization to first occurrence of distant metastasis or death from any cause, assessed up to 9.5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I had surgery to remove my prostate gland.
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My lymph nodes were tested and found to be cancer-free or were not tested.
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My hemoglobin level is at least 10.0 g/dl without any medical help.
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My prostate cancer score is 7 or higher and my PSA level was above 0.2 ng/ml before starting hormone therapy.
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My cancer tissue sample is available for genetic testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of inflammatory bowel disease.
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I am currently on IV antibiotics for a bacterial or fungal infection.
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My cancer has spread to other parts of my body.
Select...
I haven't been hospitalized for lung problems in the last 15 days.
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I've had radiation in the same area where my current cancer is.
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I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of randomization to first occurrence of distant metastasis or death from any cause, assessed up to 9.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of randomization to first occurrence of distant metastasis or death from any cause, assessed up to 9.5 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
Freedom from progression (FFP) (Phase II)
Metastasis free survival (MFS) (Phase III)
Secondary study objectives
Genomic profiling in making adjuvant therapy decisions
Incidence of acute adverse events scored according to the Cancer Therapy Evaluation Program active version of the Common Terminology Criteria for Adverse Events
Late grade 3+ adverse events scored according to the Cancer Therapy Evaluation Program active version of the Common Terminology Criteria for Adverse Events
+3 more
Other study objectives
DECIPHER signature in predicting response

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (androgen deprivation therapy, EBRT, docetaxel)Experimental Treatment11 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 over 1 hour on day 1 of every 21 days for 6 cycless in the absence of disease progression or unexpected toxicity.
Group II: Arm I (androgen deprivation therapy, EBRT)Active Control10 Interventions
Patients receive androgen deprivation therapy comprising leuprolide acetate, goserelin acetate, degarelix, 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
Leuprolide Acetate
2002
Completed Phase 3
~1890
Degarelix
2002
Completed Phase 3
~3730
External Beam Radiation Therapy
2006
Completed Phase 3
~3300
Leuprolide
2008
Completed Phase 4
~19000
Goserelin
2008
Completed Phase 3
~4270
Bicalutamide
2003
Completed Phase 3
~6210
Goserelin Acetate
2007
Completed Phase 3
~1040
Docetaxel
1995
Completed Phase 4
~6550
Flutamide
2013
Completed Phase 4
~2110
Nilutamide
1996
Completed Phase 3
~310

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
237 Previous Clinical Trials
102,162 Total Patients Enrolled
20 Trials studying Prostate Cancer
12,301 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,020,325 Total Patients Enrolled
569 Trials studying Prostate Cancer
529,860 Patients Enrolled for Prostate Cancer
Mark D HurwitzPrincipal InvestigatorNRG Oncology

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
~107 spots leftby May 2026
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