Radium 223 Following Intermittent ADT

NCT02656563 | Withdrawn Phase 2 DMC

• 2 other identifiers: CURC-00417848
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PSA > 5.0ng/ml

  Time to PSA \> 5.0ng/ml in the off treatment interval during intermittent androgen ablation therapy, as measured from randomization.

  Time to PSA > 5.0ng/ml in the off treatment, through study completion at 2 years.

Study Arms (2)

Radium 223 Arm

EXPERIMENTAL

Radium 223 Dichloride (Xofigo®)

Radiation: Radium 223 Dichloride (Xofigo®)

Non Treatment Arm

NO INTERVENTION

Control Arm

Interventions

Radium 223 Dichloride (Xofigo®) RADIATION

Radium 223 Dichloride (Xofigo®) monthly for six months

Also known as: Xofigo®

Radium 223 Arm

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read and write (health outcome questionnaires are self- administered), understand instructions related to study procedures and to give written informed consent.
• Age ≥ 45 and ≤ 85 years.
• Histologically documented diagnosis (including Gleason grade) of adenocarcinoma of the prostate.
• 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.
• Subject has completed intermittent androgen ablation therapy or is about to complete ADT.
• Patients treated with brachytherapy must be at least 3 years post implant.
• 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
• Adequate hematological, liver, and renal function including:

You may not qualify if:

• 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
• 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.
• 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.
• Subject has received adjuvant or neoadjuvant androgen ablation within the previous 12 months.
• Any unstable serious co-existing medical condition(s) including but not limited to uncontrolled diabetes, peptic ulcer disease, Crohn's disease and ulcerative colitis.
• 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)

Sponsors & Collaborators

• Canadian Urology Research Consortium: lead
• Bayer: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Laurence Klotz, MD

  Canadian Urology Research Consortium

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: January 15, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

CA (1)