Prostate Cancer Clinical Trial

A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer

Summary

The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.

NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.

Males 18 years of age and above
Histological or cytological proof of prostate cancer

Documented progressive mCRPC based on at least one of the following criteria:

PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng/mL.
Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.
Progression of bone disease (evaluable disease) or two or more new bone lesions by bone scan.
Two or more bone lesions
ECOG 0- 1

Normal organ function with acceptable initial laboratory values within 14 days of randomization:

Albumin > 30 g/L
ANC ≥ 1.5 x 10^9/L
Hemoglobin ≥ 10 g/dL
Platelet count ≥ 100 x 10^9/L
Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)
Bilirubin ≤ ULN (unless documented Gilbert's disease)
SGOT (AST) ≤ 1.5 x ULN
SGPT (ALT) ≤ 1.5 x ULN
WBC count ≥ 3 x 10^9/L
Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 30 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
Serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy.
All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less.
Willing and able to comply with the protocol, including follow-up visits and examinations

Exclusion Criteria:

Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization.
Received external beam radiotherapy within the 4 weeks prior to randomization.
Has an immediate need for external beam radiotherapy.
Has received any systemic bone-seeking radiopharmaceutical in the past.
Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel.

Has received four or more systemic anticancer regimens for mCRPC.

Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC
A 'line' is a regimen. Combinations of hormones and other types of therapies count as single lines.
Has known Grade ≥3 docetaxel-related toxicities or docetaxel toxicity related dose interruption or discontinuation.
Has received blood transfusions or growth factors within the last 4 weeks prior to randomization.
Symptomatic nodal disease (i.e., scrotal, penile, or leg edema).
Has visceral metastases with ≥ 3 lung and/or liver metastases or individual lesion ≥2 cm, as assessed by CT scan or MRI of the chest/abdomen/pelvis within the last 8 weeks prior to randomization.
Symptomatic loco-regional disease that causes ongoing Grade 3 or Grade 4 urinary or rectal symptoms.
Subjects with a "currently active" second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Subjects are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
Has imminent or established cord compression based on clinical findings and/or MRI.
Known bone marrow dysplasia
Has received any of the following in the 4 weeks prior to randomization: 5-alpha-reductase inhibitors, herbal medications, natural hormonally active foods (e.g., phytoestrogens) or other food supplements known to alter PSA in humans

Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to:

Uncontrolled infection
NYHA III or IV heart failure
Crohn's disease or those with ulcerative colitis who have not undergone a colectomy
Known active infection with HIV, Hepatitis B or Hepatitis C

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

738

Study ID:

NCT03574571

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 50 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Isaac Bowman, MD
Contact
[email protected]
Yale University- Yale Cancer Center
New Haven Connecticut, 06510, United States More Info
Michael Hurwitz, MD, MPH, MsC
Contact
877-925-3637
[email protected]
Helen Graham Cancer Center (Christiana Care)
Newark Delaware, 19713, United States More Info
Jamal Misleh, MD
Contact
[email protected]
Boca Raton Regional Hospital
Boca Raton Florida, 33486, United States More Info
Alan Koletsky, MD
Contact
561-955-6400
Mount Sinai Medical Center (Miami)
Miami Florida, 33140, United States More Info
Mike Cusnir, MD
Contact
305-535-3300
[email protected]
Rush University Medical Center
Chicago Illinois, 60601, United States More Info
Dian Wang, MD, PhD
Contact
312-942-5751
Indiana University
Indianapolis Indiana, 46202, United States More Info
Nabil Adra, MD
Contact
317-944-5349
[email protected]
Ochsner Cancer Institute
New Orleans Louisiana, 70121, United States More Info
Marc Matrana, MD
Contact
504-842-3910
University of Maryland Medical Center
Baltimore Maryland, 21201, United States More Info
Arif Hussain, MD
Contact
410-328-7225
University of Massachusetts
Worcester Massachusetts, 01655, United States More Info
Kriti Mittal, MD, MS
Contact
508-334-3550
University of Michigan Cancer Center
Ann Arbor Michigan, 48109, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States More Info
Gautam Jha, MD
Contact
612-884-0600
Nebraska Cancer Specialists
Omaha Nebraska, 68114, United States More Info
Ralph Hauke, MD, FACP
Contact
402-354-8124
XCancer Omaha / Urology Cancer Center
Omaha Nebraska, 68130, United States More Info
Luke Nordquist, MD
Contact
402-991-8468
[email protected]
Tony Romero
Contact
402-697-2229
[email protected]
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89128, United States More Info
Restituto Tibayan, MD
Contact
[email protected]
Memorial Sloan Kettering Basking Ridge
Basking Ridge New Jersey, 07920, United States More Info
Michael Morris, MD
Contact
646-422-4469
MD Anderson Cancer Center at Cooper
Camden New Jersey, 08103, United States More Info
David Mulvihill, MD
Contact
856-735-6396
Memorial Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States More Info
Michael Morris, MD
Contact
646-422-4469
Memorial Sloan Kettering Bergen
Montvale New Jersey, 07645, United States More Info
Michael Morris, MD
Contact
646-422-4469
New Jersey Urology
Saddle Brook New Jersey, 07663, United States More Info
Elan Diamond, MD
Contact
973-873-7029
New Mexico Oncology and Hematology
Albuquerque New Mexico, 87109, United States More Info
Gregg Franklin, MD
Contact
[email protected]
University of Buffalo
Buffalo New York, 14203, United States More Info
Roberto Pili, MD
Contact
716-898-4328
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Memorial Sloan Kettering Commack
Commack New York, 11725, United States More Info
Michael Morris, MD
Contact
646-422-4469
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States More Info
Michael Morris, MD
Contact
646-422-4469
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Michael Morris, MD
Contact
646-422-4469
Josef Fox, MD
Contact
212-639-7371
Michael Morris, MD
Principal Investigator
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York New York, 10065, United States More Info
Scott Tagawa, MD
Contact
646-962-2072
Bronx VA Hospital
New York New York, 10468, United States More Info
Antonio Fojo, MD, PhD
Contact
718-584-9000
University of Rochester Medical Center
Rochester New York, 14642, United States More Info
Chunkit Fung, MD
Contact
585-275-5823
Memorial Sloan Kettering Rockville Centre
Rockville Centre New York, 11570, United States More Info
Michael Morris, MD
Contact
646-422-4469
Memorial Sloan Kettering Nassau
Uniondale New York, 11553, United States More Info
Michael Morris, MD
Contact
646-422-4469
University of North Carolina
Chapel Hill North Carolina, 27514, United States More Info
Young Whang, MD, PhD
Contact
984-974-0000
Atrium Health/ Levine Cancer Institute
Monroe North Carolina, 28112, United States More Info
Earle Burgess, MD
Contact
[email protected]
University of Cincinnati Medical Center
Cincinnati Ohio, 45219, United States More Info
Robert Franklin, MD
Contact
[email protected]
Dayton Physicians Network
Kettering Ohio, 45409, United States More Info
Charles Bane, MD
Contact
[email protected]
University of Oklahoma
Oklahoma City Oklahoma, 73104, United States More Info
Adanma Ayanambakkam, MD
Contact
[email protected]
MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States More Info
Laurence Belkoff, DO
Contact
610-667-3020
Medical University of South Carolina
Charleston South Carolina, 29425, United States More Info
Toros Dincman, MD
Contact
[email protected]
Houston Methodist Research Institute
Houston Texas, 77030, United States More Info
Eleni Efstathiou, MD
Contact
[email protected]
Millennium Physicians
Houston Texas, 77090, United States More Info
Umang Patel, MD
Contact
281-440-5006
University of Washington
Seattle Washington, 98109, United States
Noordwest Ziekenhuisgrouep Alkmaar (NWZ)
Alkmaar , 1815, Netherlands More Info
M. Hendriks, MD
Contact
+31 72 5482872
Ziekenhuisgroep Twente (ZGT)
Almelo , 7609, Netherlands More Info
I.M. Oving, MD
Contact
+31-887083782
[email protected]
Amphia Hospital
Breda , 4818, Netherlands More Info
H.M. Westgeet, MD
Contact
[email protected]
Haaglanden Medical Center
Den Haag , 2512, Netherlands More Info
H Helgason, MD
Contact
[email protected]
Deventer Ziekenhuis
Deventer , , Netherlands More Info
A.L.T. Imholz, MD
Contact
[email protected]
Tergooi Hospital
Hilversum , 1213, Netherlands More Info
H.P. van den Berg, MD
Contact
+31-887535153
[email protected]
Canisius Wilhelmina Ziekenhuis (CWZ)
Nijmegen , 6532, Netherlands More Info
D.M. Somford, MD
Contact
[email protected]
Erasmus MC Cancer Institute
Rotterdam , 3015 , Netherlands More Info
Ronald de Wit, MD, PhD
Contact
+31-107040704
[email protected]
Franciscus Gasthuis & Vlietland
Rotterdam , 3045, Netherlands More Info
P. Hamberg, MD
Contact
+31-104616295
[email protected]
Maasstad Hospital
Rotterdam , 3079, Netherlands More Info
B.C.M. Haberkom, MD
Contact
+31-102911911
[email protected]
St. Antonius Ziekenhuis (Utrecht)
Utrecht , , Netherlands More Info
Cornelis Hunting, MD
Contact
[email protected]
Isala Kliniek
Zwolle , 8025, Netherlands More Info
Metin Tascilar, MD
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

738

Study ID:

NCT03574571

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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