CompletedPhase 2

Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer.

United States52 participantsStarted 2017-03-01

Plain-language summary

The purpose of this study is to look at patient outcomes when docetaxel is started prior to ADT with degarelix.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histological or cytological diagnosis of adenocarcinoma of the prostate.
. Metastatic disease identified via radiographic assessment by CT scans of the chest, abdomen, pelvis, and nuclear bone scan. MRI may be used if deemed necessary by the investigator. See Section 8.5 for more details about radiographic assessment requirements.
. Any visceral metastases identified by CT scans or MRI.
. Site(s) of bony metastasis identified by nuclear bone scan, MRI, and/or CT scan.
. Lymph node based disease not considered to be within a single radiation therapy port (e.g. at or above the aortic bifurcation.)
. Non-castrate testosterone level, \>50 ng/dl, at study enrollment.
. Age greater than or equal to 18 years.
. ECOG performance status 0-2.

Exclusion criteria

. CNS metastases (brain or leptomeningeal).
. Osseous metastases felt in the opinion of the clinician to be high-risk for impending pathologic fracture or spinal cord compression.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PSA Response at 10 Months

Timeframe: 10 months

Trial details

NCT IDNCT03069937

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-03

Results submitted2025-02-05

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