Prostate Cancer Clinical Trial
Official title:
Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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.
Status | Recruiting |
Enrollment | 738 |
Est. completion date | June 1, 2026 |
Est. primary completion date | June 1, 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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: 1. 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. 2. 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. 3. 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Noordwest Ziekenhuisgrouep Alkmaar (NWZ) | Alkmaar | |
Netherlands | Ziekenhuisgroep Twente (ZGT) | Almelo | |
Netherlands | Nederlands Kanker Instituut (Data Collection Only) | Amsterdam | Plesmanlaan 121 |
Netherlands | Amphia Hospital | Breda | |
Netherlands | Haaglanden Medical Center | Den Haag | |
Netherlands | Deventer Ziekenhuis | Deventer | |
Netherlands | Tergooi Hospital | Hilversum | |
Netherlands | Canisius Wilhelmina Ziekenhuis (CWZ) | Nijmegen | |
Netherlands | Erasmus MC Cancer Institute | Rotterdam | |
Netherlands | Franciscus Gasthuis & Vlietland | Rotterdam | |
Netherlands | Maasstad Hospital | Rotterdam | |
Netherlands | St. Antonius Ziekenhuis (Utrecht) | Utrecht | |
Netherlands | Isala Kliniek | Zwolle | |
Spain | Hospital Del Mar (Data Collection Only) | Barcelona | |
Spain | Vall d'Hebron Institute of Oncology (VHIO) (Data Collection Only) | Barcelona | |
Spain | Hospital Universitario 12 de Octubre (Data Collection Only) | Madrid | |
Spain | Ramón y Cajal Hospital | Madrid | Community Of Madrid |
Spain | HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO (Data Collection Only) | Sevilla | |
Spain | Instituto Valenciano de Oncología (Data Collection Only) | Valencia | |
United States | New Mexico Oncology and Hematology | Albuquerque | New Mexico |
United States | University of Michigan Cancer Center | Ann Arbor | Michigan |
United States | MidLantic Urology | Bala-Cynwyd | Pennsylvania |
United States | University of Maryland Medical Center | Baltimore | Maryland |
United States | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey |
United States | Boca Raton Regional Hospital | Boca Raton | Florida |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Buffalo | Buffalo | New York |
United States | MD Anderson Cancer Center at Cooper | Camden | New Jersey |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
United States | Memorial Sloan Kettering Commack | Commack | New York |
United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
United States | Memorial Sloan Kettering Westchester | Harrison | New York |
United States | Houston Methodist Research Institute | Houston | Texas |
United States | Millennium Physicians | Houston | Texas |
United States | Indiana University | Indianapolis | Indiana |
United States | Dayton Physicians Network | Kettering | Ohio |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | Mount Sinai Medical Center (Miami) | Miami | Florida |
United States | Memorial Sloan Kettering Monmouth | Middletown | New Jersey |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Atrium Health/ Levine Cancer Institute | Monroe | North Carolina |
United States | Memorial Sloan Kettering Bergen | Montvale | New Jersey |
United States | Yale University- Yale Cancer Center | New Haven | Connecticut |
United States | Ochsner Cancer Institute | New Orleans | Louisiana |
United States | Bronx VA Hospital | New York | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | New York Presbyterian Hospital-Weill Medical College of Cornell University | New York | New York |
United States | Helen Graham Cancer Center (Christiana Care) | Newark | Delaware |
United States | University of Oklahoma | Oklahoma City | Oklahoma |
United States | Nebraska Cancer Specialists | Omaha | Nebraska |
United States | XCancer Omaha / Urology Cancer Center | Omaha | Nebraska |
United States | University of Rochester Medical Center | Rochester | New York |
United States | Memorial Sloan Kettering Rockville Centre | Rockville Centre | New York |
United States | New Jersey Urology | Saddle Brook | New Jersey |
United States | University of Washington | Seattle | Washington |
United States | Memorial Sloan Kettering Nassau | Uniondale | New York |
United States | University of Massachusetts | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Bayer |
United States, Netherlands, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Overall survival is defined as the time from randomization to death from any cause. | 2 years |
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