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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Canadian Urology Research Consortium
- Locations
- 1
- Primary Endpoint
- PSA > 5.0ng/ml
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.