Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Radium 223 Following Intermittent ADT (RAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02656563
Recruitment Status : Withdrawn
First Posted : January 15, 2016
Last Update Posted : October 14, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Canadian Urology Research Consortium

Brief Summary:
This is a multicentre, phase II, randomized, open label study to evaluate the efficacy and safety of monthly Radium 223 in prolonging the off treatment interval of men with localized prostate cancer receiving intermittent androgen ablation therapy for a rising PSA post-radiation or post-prostatectomy, who are at high risk for occult metastases.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radium 223 Dichloride (Xofigo®) Phase 2

Detailed Description:

Eligible subjects will be randomized in a 1:1 ratio to receive either (1) study medication, Radium 223 monthly for six months or (2) no treatment (usual care). All patients will have a physical exam, PSA, testosterone and clinical lab tests conducted monthly. Group 1 will receive monthly Radium 233 beginning one month after discontinuing ADT, for a maximum of 6 months of treatment. Radium-223 will be given in accordance with the Canadian product label and Product Monograph at 50kBq/kg.

If PSA reaches 5ng/ml before 7 months after discontinuing ADT, the patient will discontinue Radium 223 and resume ADT. Group 2 will have no further therapy until their PSA reaches 5ng/ml, at which point they will resume ADT.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Open Label to Evaluate Efficacy,Safety of Radium 223 in Prolonging the Off Treatment Interval in Men With Rising PSA Post-rad, or Post-prostatectomy Without Bone Mets on Intermittent Androgen Ablation Therapy
Study Start Date : October 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radium 223 Arm
Radium 223 Dichloride (Xofigo®)
Radiation: Radium 223 Dichloride (Xofigo®)
Radium 223 Dichloride (Xofigo®) monthly for six months
Other Name: Xofigo®

No Intervention: Non Treatment Arm
Control Arm



Primary Outcome Measures :
  1. PSA > 5.0ng/ml [ Time Frame: Time to PSA > 5.0ng/ml in the off treatment, through study completion at 2 years. ]
    Time to PSA > 5.0ng/ml in the off treatment interval during intermittent androgen ablation therapy, as measured from randomization.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to read and write (health outcome questionnaires are self- administered), understand instructions related to study procedures and to give written informed consent.
  2. Age ≥ 45 and ≤ 85 years.
  3. Histologically documented diagnosis (including Gleason grade) of adenocarcinoma of the prostate.
  4. Subject has received external beam radiation, brachytherapy or radical prostatectomy for the treatment of localized prostate cancer, or is being treated with primary androgen deprivation.
  5. Subject has completed intermittent androgen ablation therapy or is about to complete ADT.
  6. Patients treated with brachytherapy must be at least 3 years post implant.
  7. Subject meets both of the following criteria:

    • PSA >5.0 and < 100 ng/ml and rising on 2 successive occasions at least one month apart prior to ADT. PSA must be < 2.0 after 6-8 months of ADT (+/- 4 weeks). At month 8 (or within 4 weeks after month 8), following documentation that PSA <2.0, patients will be entered.
    • Patients must also have two of the following high risk criteria:

      • Primary Gleason score >8
      • Baseline PSA > 20 ng/ml (pre-treatment)
      • PSA recurrence > 0.2 within 1 year (post RP)
      • PSA DT prior to ADT < 6 months
      • PSA > 1.0 ng/ml after 8 months of ADT
  8. Adequate hematological, liver, and renal function including:

    • Absolute neutrophil count (ANC) ≥ 1.5 x109/L
    • Platelet count ≥ 100 x109/L
    • Hemoglobin ≥10.0 g/dL (100 g/L; 6.2 mmol/L)
    • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    • Albumin > 25 g/L
  9. Eastern Cooperative Oncology Group Performance (ECOG) performance 0 or 1 (Appendix 2).
  10. Negative bone scan and negative CT scan for visceral (extra nodal) mets within 12 months of study entry. Bone scan and CT may be performed after initiation of ADT. If lymphadenopathy present, must be <3 cm in shortest diameter.
  11. Able to swallow and retain oral medication.
  12. Able and willing to participate in the full study.
  13. Willingness to use condoms if sexually active.

Exclusion Criteria:

  1. Previous treatment for prostate cancer with any of the following:

    • Chemotherapy
    • Hormonal therapy (e.g. megestrol, medroxyprogesterone, cyproterone, DES) within the previous year. (Note: Patients who are on their first cycle of intermittent androgen deprivation therapy within 8 months of initiating treatment are eligible).
    • Glucocorticoids (except inhaled or topical) within the previous 3 months.
    • Ketoconazole
  2. Concurrent and previous use within 3 months of the following medications:

    • Finasteride
    • Dutasteride
    • Any investigational 5α-reductase inhibitors
    • Anabolic steroids
    • Medications with anti-androgenic properties such as cimetidine.
  3. Patients may not be receiving any other investigational agents within 30 days prior to the first dose of study drug or anytime during the study period.
  4. Subject currently has evidence of distant metastases on bone scan, or visceral metastases on CT scan. Patients with bulky LN mets. (> 3 cm in shortest diameter). (Note: Adenopathy < 3 cm in shortest diameter is not an exclusion criterion).
  5. Subject has received adjuvant or neoadjuvant androgen ablation within the previous 12 months.
  6. Any unstable serious co-existing medical condition(s) including but not limited to uncontrolled diabetes, peptic ulcer disease, Crohn's disease and ulcerative colitis.
  7. Abnormal liver function tests (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST]) > 2.5 times upper limit of normal (ULN) or bilirubin > 1.5 times ULN)
  8. Previous malignancy (not including curatively treated basal or squamous cell carcinoma of the skin within the previous 2 years or Ta bladder cancer with negative surveillance cystoscopy within the past year).
  9. History or current evidence of drug or alcohol abuse within the past 12 months.
  10. History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject. This includes:

    • Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered.
    • Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
    • Cardiac Failure New York Heart Association (NYHA) Class III or IV
    • Bone marrow dysplasia
    • Fecal incontinence
  11. Prior hemibody external radiotherapy, or systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656563


Locations
Layout table for location information
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Canadian Urology Research Consortium
Bayer
Investigators
Layout table for investigator information
Study Chair: Laurence Klotz, MD Canadian Urology Research Consortium

Layout table for additonal information
Responsible Party: Canadian Urology Research Consortium
ClinicalTrials.gov Identifier: NCT02656563     History of Changes
Other Study ID Numbers: CURC-004
17848 ( Other Identifier: Bayer )
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Radium Ra 223 dichloride
Antineoplastic Agents