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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:

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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.

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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 weeks3 visits

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

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

2008

Completed Phase 4

~19040

External Beam Radiation Therapy

2006

Completed Phase 3

~3300