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

Phase 3

Recruiting

Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
prostate cancer
10038597

Registration Number: NL-OMON54758

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 250

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.
• 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 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/m 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
• Subjects must agree to use a medically acceptable method of birth control 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.

Exclusion Criteria

Exclusion Criteria:
• Received 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.
o Treatment with docetaxel or abiraterone for non-castrate metastatic disease
is permissible and does not count towards the lines of therapy for mCRPC
o 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, 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:
o Uncontrolled infection
o NYHA III or IV heart failure
o Crohn's disease or those with ulcerative colitis who have not undergone a
colectomy
o Known active infection with HIV, Hepatitis B or Hepatitis C

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The overall survival comparison between treatments will be evaluated at each<br /><br>interim analysis and the final analysis using the stratified logrank test. The<br /><br>stratification factors are:<br /><br>• Prior docetaxel for castrate sensitive disease<br /><br>• Visceral disease (presence or absence)</p><br>

Secondary Outcome Measures