Trial comparing subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) treated with Docetaxel vs. subjects treated with a combination of Docetaxel and Radium-223

Phase 1

• Conditions: Patients with histological or cytological proof of Metastatic Castration-Resistant Prostate Cancer (mCRPC); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002944-10-NL
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-20
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 738

Inclusion Criteria

Inclusion Criteria:
•Willing and able to provide, or have a legally authorized representative 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.a)PSA progression defined as a minimum of 2 rising PSA levels with a minimum of a 1 week interval between each determination. A minimum PSA of 1.0 ng/mL is required for study entry.
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 defined by nuclear bone scan
•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

•3.1.8Subjects 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 6 months after the last dose of study drug. Sperm donation is prohibited during the study and for 6 months 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 148
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 590

Exclusion Criteria

Exclusion Criteria:
•3.2.1Received any other investigational therapeutic agents or other anticancer therapies within 2 weeks or 5 half-lives, whichever is shorter, prior to randomization.
•Received external beam radiotherapy within the 2 weeks prior to randomization.
•Has an immediate need for external beam radiotherapy.
•Has received any other systemic investigational or anti-cancer radiopharmaceutical in the past.
•Has received any prostate cancer directed chemotherapy in the castration resistant setting.
•Has received > 6 prior doses of docetaxel in the castration sensitive 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 non-hematological 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 second malignancy with a risk of recurrence >30% within the next 3 years. Non-melanoma skin cancers, non-invasive bladder cancers, and other in-situ or non-invasive malignancies are permitted while on study.
•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
•Is receiving ongoing treatment with herbal medications that are known in humans to alter PSA or the natural history of prostate cancer. Subjects must discontinue any such herbal medications prior to the first dose of study drug
•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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified