Prostate CancerPhase 2RANDNCT02656563
Radium 223 Following Intermittent ADT
A Phase 2 study testing Radium 223 Dichloride (Xofigo®) in people with Prostate Cancer, run by Canadian Urology Research Consortium at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radium 223 Dichloride (Xofigo®)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Oct 2020
- 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 45 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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
- Eastern Cooperative Oncology Group Performance (ECOG) performance 0 or 1 (Appendix 2).
- 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.
- Able to swallow and retain oral medication.
- Able and willing to participate in the full study.
- Willingness to use condoms if sexually active.
Who cannot join
- 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:
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- 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 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).
- 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)
- 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).
- History or current evidence of drug or alcohol abuse within the past 12 months.
- 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
- Prior hemibody external radiotherapy, or systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Radium 223 Dichloride (Xofigo®)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium 223 Dichloride (Xofigo®)Radiation
Also called Xofigo®
Radium 223 Dichloride (Xofigo®) monthly for six months
| Study group | Role | What they receive |
|---|---|---|
| Radium 223 Arm | Experimental | Radium 223 Dichloride (Xofigo®) Receives: Radiation: Radium 223 Dichloride (Xofigo®) |
| Non Treatment Arm | No intervention | Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA > 5.0ng/ml
Time to PSA > 5.0ng/ml in the off treatment interval during intermittent androgen ablation therapy, as measured from randomization.
Measured: Time to PSA > 5.0ng/ml in the off treatment, through study completion at 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Urology Research Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Laurence Klotz, MD, Study chair, Canadian Urology Research Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656563
- Sponsor's protocol ID
- CURC-004
- Other IDs
- 17848
- Acronym
- RAND
- Status last verified
- Oct 2016
- First submitted
- 5 Nov 2015
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02656563
- Acronym / sponsor ID
- RAND / CURC-004
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Canadian Urology Research ConsortiumUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Oct 2015
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radium 223 Arm | Experimental | Radiation: Radium 223 Dichloride (Xofigo®)Radium 223 Dichloride (Xofigo®) |
| Non Treatment Arm | No intervention | –Control Arm |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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.
Key exclusion criteria (25 listed)
- Previous treatment for prostate cancer with any of the following:
- Concurrent and previous use within 3 months of the following medications:
- 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 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).
- Subject has received adjuvant or neoadjuvant androgen ablation within the previous 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radium 223 Dichloride (Xofigo®)Also: Xofigo®Radium 223 Dichloride (Xofigo®) monthly for six months | Radiation | Radium 223 Arm |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Klotz, MD study chair
Canadian Urology Research Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radium 223 Dichloride (Xofigo®) in people with Prostate Cancer, run by Canadian Urology Research Consortium at 1 site in Canada.
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 26 inclusion and 25 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: withdrawn, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
PSA > 5.0ng/ml (time frame: Time to PSA > 5.0ng/ml in the off treatment, through study completion at 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2016.