AzTrials
AzTrials

Prostate Carcinoma Metastatic to the BonePhase 2NCT02507570

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

A Phase 2 study testing Enzalutamide and Radium ra 223 dichloride in people with Prostate Carcinoma Metastatic to the Bone, run by Carolina Research Professionals, LLC at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Enzalutamide and Radium ra 223 dichloride
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesUnited States
Study dates
23 Sep 2015to 18 Jan 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible subjects will conform to all of the inclusion criteria listed below:
  • 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.
Show all 20Show fewer
  • Subject must:
  • 1. 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.
  • 7. Subject must plan to receive all 6 Radium Ra 223 dichloride injections and daily oral doses of Enzalutamide during the study, per protocol.
  • 8. 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:
  • 1. 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).
  • 9. 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.
  • 10. 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).
  • 11. Subject has an ECOG performance status of 0-2 at the screening and enrollment visits.
  • 12. Acceptable hematology and serum biochemistry screening values: White Blood Cell (WBC) >/= 3,000/mm3 Absolute Neutrophil Count (ANC) >1500/mm3 Platelet (PLT) count >100,000/mm3 Hemoglobin (HGB) > 10.0 g/dL (100g/L; 6.2 mmol/L Creatinine <1.5 ULN Total bilirubin level <1.5 X ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 X ULN albumin >25 g/L Baseline electrolytes within normal limits ( Sodium, potassium, chloride, calcium, phosphate, magnesium, LDH, γGT, urea, total protein)
  • 13. Normal Liver Function Tests (LFT) and normal Renal Function Tests (RFT) at the screening visit. If the subject has LFT's or RFT's greater than 2.5 times the upper limit of normal (ULN), Medical Monitor review, in conjunction with the subject's PI, will be required.
  • 14. Subjects receiving Anti-Resorptive medications, such as denosumab (XGEVA) and Zolendronic Acid (Zometa), must be on a stable dose for at least 90 days prior to enrollment (Cycle 1/Week 1/Day 1). Anti-resorptive medications may be not be added to the subject's regimen during the study. Anti-resorptive discontinuation will be allowed per Investigator discretion due to adverse events attributable to that medication.
  • 15. Subjects of childbearing potential must agree to use adequate contraception beginning at the enrollment until at least 30 days after the last dose of the study drugs. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.

Who cannot join

  • Eligible subjects must not meet any of the exclusion criteria listed below:
  • 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).
Show all 24Show fewer
  • 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 had treatment with cytotoxic chemotherapy within 4 weeks or enrollment (Cycle 1/Week 1/Day 1), or planned prior to the End of Treatment visit or the last Long Term Follow Up visit, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks prior to enrollment (Cycle 1/Week 1/Day 1), such as persistent myelosuppression, GI toxicity, or severe fatigue. Ongoing neuropathy is not exclusionary.
  • 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 a history of any other malignancy within the previous 5 years. A history of squamous or basal cell carcinoma or low-grade superficial bladder cancer that has been adequately treated at least 12 months prior to enrollment is not exclusionary.
  • 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.
  • Subject has a serious concurrent medical condition or psychiatric illness.
  • Subject has a history of other serious illness of medical condition including, but not limited to any uncontrolled infection, congestive heart failure New York Heart Association (NYHA) class III or IV, Crohn's Disease or Ulcerative Colitis, uncontrolled hypertension or Bone Marrow Dysplasia at screening.
  • Subject has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, active peptic ulcer disease within 90 days prior to enrollment (Cycle 1/Week 1/Day 1)
  • Subject is not able to swallow the study treatment capsules.
  • Subject has unmanageable fecal incontinence.
  • Subject has any condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Associated Medical Professionals

    Syracuse, New York, 13210

  • Chesapeake Urology Research Associates

    Towson, Maryland, 21204

  • Urology of Virginia, PLLC

    Virginia Beach, Virginia, 23462

Other trials in United States

About this study

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.

Read the detailed description

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 metastasis, in both the pre- and post- chemotherapy setting.

Radium Ra 223 dichloride is approved by the US Food and Drug Administration for this indication. Enzalutamide is US Food and Drug Administration approved for this indication.

Approximately 40 subjects will be enrolled to obtain 30 evaluable subjects. All subjects will receive Radium Ra 223 dichloride every 4 weeks for a total of 6 doses over 24 weeks and concurrent Enzalutamide for a minimum duration of 24 weeks. The sponsor will provide Enzalutamide after the End of Treatment visit until the last Long Term Follow Up visit has been completed. Subjects will continue to receive Enzalutamide as long as a positive response to therapy is demonstrated. Enzalutamide may be discontinued at any time per physician discretion.

Subjects will be evaluated 30 days after the last dose of Radium Ra 223 dichloride. Including screening, the total duration of the study is 32 weeks plus every 3 month follow up visits while subjects are receiving Enzalutamide.

Being tested
Enzalutamide, Radium ra 223 dichloride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnzalutamideDrug

    Also called XTANDI and Xofigo

    used concomitantly

  • Radium ra 223 dichlorideRadiation

Study groups in NCT02507570
Study groupRoleWhat they receive
Open labelExperimentalSingle arm study to evaluate safety and tolerability of Enzalutamide with concurrent administration of Radium ra 223 dichloride in subjects with symptomatic metastatic prostate cancer.
Receives: Drug: Enzalutamide; Radiation: Radium ra 223 dichloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (9)

  1. Bone pain measured by the Bone Pain Index- Short Form questionnaire

    Bone Pain

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

  2. Quality of Life Questionnaire

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

  3. Time to measurable disease progression

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

  4. Time to implementation of palliative radiotherapy

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

  5. Time to analgesic (Opioid) advancements

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

  6. Time from start of Enzalutamide to PSA progression

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

  7. Changes and time to total-ALP progression will be measured by recording laboratory values

    Changes and time to total-ALP progression

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

  8. Progression to additional antineoplastic therapy will be measured by tracking subject diaries and concomitant medications

    Progression to additional antineoplastic therapy

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

  9. Performance status change will be measured by ECOG status

    Performance status change

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2015 (estimated)
  2. Study start23 Sep 2015
  3. Primary completion18 Jan 2019
  4. Study completion18 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02507570
Sponsor's protocol ID
CRP-PCA-02 EnzaRadiCate
Status last verified
Mar 2019
First submitted
16 Jul 2015
Last updated
19 Mar 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enzalutamide and Radium ra 223 dichloride in people with Prostate Carcinoma Metastatic to the Bone, run by Carolina Research Professionals, LLC at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 30 days after the last cycle of Radium Ra 223 dichloride, which will be approximately 7 months after study enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02507570.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in