Study Details

Open

DORA

The purpose of this research is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. The addition of radium223 to docetaxel could be a better cancer treatment than just docetaxel alone, but it could also cause additional side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

Age & Gender

18 years ~ 99 years
Male

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

The study involves physical exam, vital signs, ECG, blood draws for labs and research, Bone scan, X-Ray or CT and/or MRI, paper questionnaires, study drug, and study drug injections.

Incentives

es, Radium-223 maybe provided by the study depending on the assigned arm.

Total length of participation:
8 months on treatment and on Follow-up for the rest of your life or for as long as you wish to be on the study.

Looking for Specific Volunteers

Able to participate:

Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information, or have a legally authorized representative
Males 18 years of age or older.
Prostate cancer can be proven histologically or cytologically.
Nuclear bone scan identifies two or more bone lesions.
Willing and capable of adhering to the protocol, including follow-up visits and examinations.

Not eligible if:

Received any other investigational medicinal products or additional anticancer treatments within 2 weeks or considered clinically eliminated, whichever is shorter, prior to randomization.
External beam radiotherapy (EBRT) was administered within the two weeks preceding randomization.
Has an urgent need for EBRT.
Has received any prostate cancer-directed chemotherapy, even when the amount of testosterone in the body is reduced to very low levels, and the cancer grows.
5. Has had blood transfusions or growth factors in the four weeks preceding randomization.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Young Whang
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Prostate)
Sexual and/or Reproductive Health
Urinary and Bladder
Men's Health

IRB Number

18-2486

ClinicalTrials.gov

NCT03574571