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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03574571

Collaborator

Bayer (Industry)

738

Enrollment

Locations

Arms

77.4

Anticipated Duration (Months)

13.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Docetaxel 75 mg/m2 Drug: Docetaxel 60 mg/m2 Drug: Radium-223	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

738 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is an open-labeled, randomized, phase III study of docetaxel versus docetaxel in combination with radium-223 in subjects with mCRPC.This is an open-labeled, randomized, phase III study of docetaxel versus docetaxel in combination with radium-223 in subjects with mCRPC.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Actual Study Start Date :

Jun 19, 2018

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Docetaxel Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses. Prednisone will be given at a dose of 5mg orally twice daily.	Drug: Docetaxel 75 mg/m2 Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses.
Experimental: Docetaxel with Radium-223 Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses. Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.	Drug: Docetaxel 60 mg/m2 Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses. Drug: Radium-223 Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.

Arm

Intervention/Treatment

Experimental: Docetaxel

Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses. Prednisone will be given at a dose of 5mg orally twice daily.

Drug: Docetaxel 75 mg/m2

Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses.

Experimental: Docetaxel with Radium-223

Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses. Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.

Drug: Docetaxel 60 mg/m2

Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses.

Drug: Radium-223

Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.

Outcome Measures

Primary Outcome Measures

Overall survival [2 years]
Overall survival is defined as the time from randomization to death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner MD Anderson Cancer Center	Gilbert	Arizona	United States	85234
2	Yale University- Yale Cancer Center	New Haven	Connecticut	United States	06510
3	Helen Graham Cancer Center (Christiana Care)	Newark	Delaware	United States	19713
4	Boca Raton Regional Hospital	Boca Raton	Florida	United States	33486
5	Mount Sinai Medical Center (Miami)	Miami	Florida	United States	33140
6	Rush University Medical Center	Chicago	Illinois	United States	606012
7	Indiana University	Indianapolis	Indiana	United States	46202
8	Ochsner Cancer Institute	New Orleans	Louisiana	United States	70121
9	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
10	University of Massachusetts	Worcester	Massachusetts	United States	01655
11	University of Michigan Cancer Center	Ann Arbor	Michigan	United States	48109
12	University of Minnesota	Minneapolis	Minnesota	United States	55455
13	Nebraska Cancer Specialists	Omaha	Nebraska	United States	68114
14	GU Research Network / Urology Cancer Center	Omaha	Nebraska	United States	68130
15	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89128
16	Memoral Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
17	MD Anderson Cancer Center at Cooper	Camden	New Jersey	United States	08103
18	Memoral Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
19	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
20	New Jersey Urology	Saddle Brook	New Jersey	United States	07663
21	New Mexico Cancer Center	Albuquerque	New Mexico	United States	87109
22	University of Buffalo	Buffalo	New York	United States	14203
23	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
24	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
25	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
26	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
27	New York Presbyterian Hospital-Weill Medical College of Cornell University	New York	New York	United States	10065
28	Bronx VA Hospital	New York	New York	United States	10468
29	University of Rochester Medical Center	Rochester	New York	United States	14642
30	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York	United States	11570
31	Memorial Sloan Kettering Nassau	Uniondale	New York	United States	11553
32	University of North Carolina	Chapel Hill	North Carolina	United States	27514
33	Atrium Health/ Levine Cancer Institute	Monroe	North Carolina	United States	28112
34	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45219
35	Dayton Physicians Network	Kettering	Ohio	United States	45409
36	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
37	MidLantic Urology	Bala-Cynwyd	Pennsylvania	United States	19004
38	Medical University of South Carolina	Charleston	South Carolina	United States	29425
39	Houston Methodist Hospital	Houston	Texas	United States	77030
40	Millennium Physicians	Houston	Texas	United States	77090
41	University of Washington	Seattle	Washington	United States	98109
42	Noordwest Ziekenhuisgrouep Alkmaar (NWZ)	Alkmaar		Netherlands	1815
43	Ziekenhuisgroep Twente (ZGT)	Almelo		Netherlands	7609
44	Amphia Hospital	Breda		Netherlands	4818
45	Haaglanden Medical Center	Den Haag		Netherlands	2512
46	Deventer Ziekenhuis	Deventer		Netherlands
47	Tergooi Hospital	Hilversum		Netherlands	1213
48	Canisius Wilhelmina Ziekenhuis (CWZ)	Nijmegen		Netherlands	6532
49	Erasmus MC Cancer Institute	Rotterdam		Netherlands	3015 GD
50	Franciscus Gasthuis & Vlietland	Rotterdam		Netherlands	3045
51	Maasstad Hospital	Rotterdam		Netherlands	3079
52	St. Antonius Ziekenhuis (Utrecht)	Utrecht		Netherlands
53	Isala Kliniek	Zwolle		Netherlands	8025