Open Label Phase Two Study of Enzalutamide With Concurrent Administration of Radium Ra 223 Dichloride in Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Symptomatic Bone Metastasis

NCT02507570 | Completed Phase 2

• 1 other identifier: CRP-PCA-02 EnzaRadiCate
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

This is an open label study designed to examine the effects of Enzalutamide with concurrent administration of Radium Ra 223 dichloride in Castrate-Resistant (Hormone-Refractory) Prostate Cancer subjects with symptomatic bone metastases in both the pre- and post-chemotherapy setting.

Conditions

Prostate Carcinoma Metastatic to the Bone

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events and serious adverse events . Adverse events deemed to be related to either study medication will be followed until resolution.

  30 days after the last cycle of Radium Ra 223 dichloride, which will be approximately 7 months after study enrollment

Secondary Outcomes (9)

• Bone pain measured by the Bone Pain Index- Short Form questionnaire

  Thorughout the study and through the last follow-up visit, estimated to be 30 months after study enrollment

• Quality of Life Questionnaire

  Thorughout the study and through the last follow-up visit, estimated to be 30 months after study enrollment

• Time to measurable disease progression

  Thorughout the study and through the last follow-up visit, estimated to be 30 months after study enrollment

• Time to implementation of palliative radiotherapy

  Thorughout the study and through the last follow-up visit, estimated to be 30 months after study enrollment

• Time to analgesic (Opioid) advancements

  Thorughout the study and through the last follow-up visit, estimated to be 30 months after study enrollment

Study Arms (1)

Open label

EXPERIMENTAL

Single arm study to evaluate safety and tolerability of Enzalutamide with concurrent administration of Radium ra 223 dichloride in subjects with symptomatic metastatic prostate cancer.

Drug: Enzalutamide; Radiation: Radium ra 223 dichloride

Interventions

Enzalutamide DRUG

used concomitantly

Also known as: XTANDI and Xofigo

Open label

Radium ra 223 dichloride RADIATION

Open label

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be able to understand and be willing to sign the written Informed Consent Form. A signed IRB approved Informed Consent Form must be appropriately obtained prior to the conduct of any study-specific procedure.
• Subject is willing and able to comply with the protocol, including all study visits and procedures.
• Subject is a male, greater than 18 years at time of enrollment.
• Life expectancy of at least 9 months.
• Subject has histologically documented prostate cancer confirmed by a pathology report from a prostate biopsy or radical prostatectomy specimen.
• Subject must:
• \. have initiated a stable dose of daily Enzalutamide within 45 days of enrollment (Cycle 1/Week 1/ Day 1), or 2. plans to initiate a stable daily dose of Enzalutamide within 30 days of the first Radium Ra 223 dichloride treatment.
• \. Subject must plan to receive all 6 Radium Ra 223 dichloride injections and daily oral doses of Enzalutamide during the study, per protocol.
• \. Subject has a history of bone metastasis from prostate cancer as evidenced by imaging performed within 90 days of enrollment (Cycle 1/Week 1/Day 1) from one of the following:
• \. Tc Bone Scan or 2. Sodium Fluoride PET/CT Scan
• If a bone scan is used, solitary lesions which could be contributed to causes other than prostate cancer must be confirmed with a second modality (i.e.: plain films, CT scan or MRI).
• \. Subject has Castrate Resistant Prostate Cancer, defined as having a rising PSA level and a testosterone level \</= 50ng/dl (2.0 nM/L) while receiving androgen deprivation therapy (medical or surgical castration). Subject must also plan to receive androgen deprivation therapy throughout the study.
• PSA progression is defined as having at least 2 rising PSA levels taken at least 7 days apart, with the 2nd PSA being 2.0 ng/dl or greater.
• \. Subject has the presence of cancer related bone pain requiring treatment with analgesic medications (including but not limited to acetaminophen, NSAIDS, Cox-2 inhibitors, and narcotic opioids).
• \. Subject has an ECOG performance status of 0-2 at the screening and enrollment visits.

You may not qualify if:

• Subject has known malignant pleural effusion, or known lung, liver or brain metastasis (lymph node only metastasis \<6 cm in short-axis diameter is allowed).
• Subject has a history of seizure or any condition that may predispose him to seizures (e.g. prior cortical stroke, significant brain trauma) at any time in the past, or a history of loss of consciousness or transient ischemic attack within 12 months of enrollment (Cycle 1/Week 1/Day 1).
• Subject has received previous treatment with Enzalutamide for longer than 45 days prior to enrollment (Cycle 1/Week 1/Day 1), or any prior treatment with Radium Ra 223 dichloride.
• Subject has a known medical contraindication to Enzalutamide or Radium Ra 223 dichloride.
• Subject is not willing to initiate a stable dose of daily Enzalutamide within 45 days of enrollment (Cycle 1/Week1/Day 1), or does not plan to initiate a stable daily dose of Enzalutamide within 30 days of the first Radium Ra 223 dichloride treatment (Cycle 1/Week 1/Day 1).
• Subject does not plan to receive all 6 injections of Radium Ra 223 Dichloride and daily Enzalutamide during the study, per protocol.
• Subject has received previous strontium-89, samarium-153, rhenium-186, or rhenium-188 for the treatment of bone metastasis within 24 weeks prior to enrollment (Cycle 1/Week 1/Day 1).
• Subject has received denosumab or Zolendronic Acid for less than 90 days prior to enrollment (Cycle 1/Week 1/Day 1), or if the subject plans to discontinue an anti-resorptive prior to the End of Treatment visit or the last Long Term Follow Up visit.
• Subject has received an investigational product or experimental therapy within 4 weeks of enrollment (Cycle 1/Week 1/Day 1), or if initiation of either is planned prior to the End of Treatment visit or the last Long Term Follow Up visit.
• Subject has a history of severe liver insufficiency (r Child-Pugh class B or C).
• Subject has a history of a myocardial infarction or cardiac arrhythmia within 6 months prior to enrollment (Cycle 1/Week 1/ Day 1).
• Subject has a history of previous radiotherapy \>25% of bone marrow, including hemibody radiation.
• Subject has undergone major surgery within 4 weeks prior to enrollment (Cycle 1/Week 1/Day 1).
• Subject has had a blood transfusion or erythropoietin stimulation agents within 4 weeks of enrollment (Cycle 1/Week 1/Day 1).
• Subject has known imminent or established spinal cord compression.

Sponsors & Collaborators

• Carolina Research Professionals, LLC: lead
• Astellas Pharma Inc: collaborator

Study Sites (4)

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

Associated Medical Professionals

Syracuse, New York, 13210, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology of Virginia, PLLC

Virginia Beach, Virginia, 23462, United States

Location

MeSH Terms

Interventions

enzalutamide; radium Ra 223 dichloride

Study Officials

• Neal D Shore, MD

  Carolina Research Professionals, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 24, 2015
• Study Start: September 23, 2015
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

US (4)