Metastatic Prostate CancerPhase 4TRANCENCT03432949
Radium-223 Combined With Dexamethasone as First-line Therapy in Patients With M+CRPC
A Phase 4 study testing Dexamethasone plus Radium-223 in people with Metastatic Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
More than 90% of patients with metastatic castration-resistant prostate cancer (mCRPC) no longer responding to androgen deprivation hormonal therapy have evidence of bone metastases. This is a major cause of death, disability, and decreased quality of life. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- Dexamethasone plus Radium-223
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 23 Feb 2018to 30 Jul 2024
- Phase
- Phase 4
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of prostate cancer
- ECOG status ≤ 2
- PSA ≥ 2.0 ng/mL
- Rising PSA in combination with new metastases or evidence of radiographic disease progression despite castrate levels of testosterone while on androgen deprivation therapy (ADT) or following bilateral orchiectomy
- Symptomatic disease defined as any analgesic use for pain or receipt of radiotherapy for bony metastatic disease
- Adequate renal and hepatic function:
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- Cr ≤ 1.5 x upper limit of normal (ULN)
- AST ≤ 2.5 x ULN
- ALT ≤ 2.5 x ULN
- Albumin > 25 g/L
- Total bilirubin ≤ 1.5 x ULN
- Adequate hematologic function
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 100 g/L
- Evidence of bone metastasis on bone scan, CT, MRI or PET
- Life expectancy ≥ 6 months
Who cannot join
- Visceral metastatic PCa (brain, liver, lung, bulky adenopathy). Note that metastatic lymphadenopathy < 3cm is acceptable for inclusion as long as there is evidence of bone metastasis.
- Previous treatment with abiraterone, enzalutamide, docetaxel or other systemic chemotherapy for PCa
- Imminent spinal cord compression or history of spinal cord compression
- Previous treatment with systemic corticosteroids for PCa at any time
- Contraindication to receipt of systemic corticosteroids (i.e. uncontrolled diabetes)
- Prior or current enrolment in any other interventional clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radium-223 Combined With Dexamethasone as First-line Therapy in Patients With Metastatic Castrate Resistant Prostate Cancer
More than 90% of patients with metastatic castration-resistant prostate cancer (mCRPC) no longer responding to androgen deprivation hormonal therapy have evidence of bone metastases. This is a major cause of death, disability, and decreased quality of life.
Radium-223 is radiopharmaceutical meaning that the drug is a radioactive compound used for therapeutic purposes. It is given intravenously (through a vein) every 4 weeks for 6 cycles. Research has demonstrated safety and efficacy in mCRPC patients resulting in radium-223 becoming a standard of care option for such patients in addition to chemotherapy and new oral hormonal drugs enzalutamide or abiraterone.
Read more
Prior research studies using radium-223 have shown improved survival in about 30% of patients. The same studies in combination with data collected from clinical use have also shown that between 20 and 50% of men do not complete the full 6 cycle course of treatment due to side effects or a rise in prostate specific antigen (PSA) requiring the stoppage of radium-223 therapy to start one of the other drug therapies.
The purpose of this study is to determine whether an oral drug called dexamethasone (a corticosteroid) given together with radium-223 may control PSA levels and reduce side effects during radium-223 treatment. Corticosteroids are anti-inflammatory medicines prescribed for a broad range of conditions and are widely used in conjunction with chemotherapy treatments for cancer. Prior research studies have shown that dexamethasone reduces PSA levels by lowering the production of androgens (i.e. male hormones) and improves overall tolerance for cancer-fighting drugs and therapies.
Up to 24 men being treated with radium-223 at University Health Network will be enrolled into this study. If the study is positive, it might offer an improved quality of life and extended survival.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- Dexamethasone plus Radium-223
- Keywords
- Radium-223, Dexamethasone, mCRPC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone plus Radium-223Drug
Also called Dexamethasone, Baycadron
Dexamethasone will be administered as 0.5 mg capsules by mouth per day during the duration of the Radium-223 treatment.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Radium-223 | No intervention | Radium-223 treatment will be administered as per standard of care. |
| Radium-223 with oral Dexamethasone 0.5 mg | Experimental | Dexamethasone will be administered as 0.5 mg capsules by mouth per day during the duration of the Radium-223 treatment. Receives: Drug: Dexamethasone plus Radium-223 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of total doses delivered on schedule
To assess the feasibility of delivering 6-treatment cycles of Radium-223 without delays when administered in combination with low-dose oral dexamethasone for patients with metastatic CRPC and bony metastases who are abiraterone, enzalutamide and systemic chemotherapy naïve.
Measured: Through infusion completion, an average of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start23 Feb 2018
- Primary completion30 Sep 2023
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432949
- Sponsor's protocol ID
- 17-5196
- Acronym
- TRANCE
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2018
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radium-223 Combined With Dexamethasone as First-line Therapy in Patients With Metastatic Castrate Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT03432949
- Acronym / sponsor ID
- TRANCE / 17-5196
- Conditions
- Metastatic Prostate Cancer
- Keywords
- Radium-223, Dexamethasone, mCRPC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 14 Feb 2018 (actual)
- 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.
More than 90% of patients with metastatic castration-resistant prostate cancer (mCRPC) no longer responding to androgen deprivation hormonal therapy have evidence of bone metastases. This is a major cause of death, disability, and decreased quality of life.
Radium-223 is radiopharmaceutical meaning that the drug is a radioactive compound used for therapeutic purposes. It is given intravenously (through a vein) every 4 weeks for 6 cycles. Research has demonstrated safety and efficacy in mCRPC patients resulting in radium-223 becoming a standard of care option for such patients in addition to chemotherapy and new oral hormonal drugs enzalutamide or abiraterone.
Prior research studies using radium-223 have shown improved survival in about 30% of patients. The same studies in combination with data collected from clinical use have also shown that between 20 and 50% of men do not complete the full 6 cycle course of treatment due to side effects or a rise in prostate specific antigen (PSA) requiring the stoppage of radium-223 therapy to start one of the other drug therapies.
The purpose of this study is to determine whether an oral drug called dexamethasone (a corticosteroid) given together with radium-223 may control PSA levels and reduce side effects during radium-223 treatment. Corticosteroids are anti-inflammatory medicines prescribed for a broad range of conditions and are widely used in conjunction with chemotherapy treatments for cancer. Prior research studies have shown that dexamethasone reduces PSA levels by lowering the production of androgens (i.e. male hormones) and improves overall tolerance for cancer-fighting drugs and therapies.
Up to 24 men being treated with radium-223 at University Health Network will be enrolled into this study. If the study is positive, it might offer an improved quality of life and extended survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Radium-223 | No intervention | –Radium-223 treatment will be administered as per standard of care. |
| Radium-223 with oral Dexamethasone 0.5 mg | Experimental | Drug: Dexamethasone plus Radium-223Dexamethasone will be administered as 0.5 mg capsules by mouth per day during the duration of the Radium-223 treatment. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Clinical diagnosis of prostate cancer
- ECOG status ≤ 2
- PSA ≥ 2.0 ng/mL
- Rising PSA in combination with new metastases or evidence of radiographic disease progression despite castrate levels of testosterone while on androgen deprivation therapy (ADT) or following bilateral orchiectomy
- Symptomatic disease defined as any analgesic use for pain or receipt of radiotherapy for bony metastatic disease
Key exclusion criteria (6 listed)
- Visceral metastatic PCa (brain, liver, lung, bulky adenopathy). Note that metastatic lymphadenopathy < 3cm is acceptable for inclusion as long as there is evidence of bone metastasis.
- Previous treatment with abiraterone, enzalutamide, docetaxel or other systemic chemotherapy for PCa
- Imminent spinal cord compression or history of spinal cord compression
- Previous treatment with systemic corticosteroids for PCa at any time
- Contraindication to receipt of systemic corticosteroids (i.e. uncontrolled diabetes)
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 |
|---|---|---|
| Dexamethasone plus Radium-223Also: Dexamethasone, BaycadronDexamethasone will be administered as 0.5 mg capsules by mouth per day during the duration of the Radium-223 treatment. | Drug | Radium-223 with oral Dexamethasone 0.5 mg |
Primary outcome
Percentage of total doses delivered on schedule
Time frame: Through infusion completion, an average of 24 weeks
To assess the feasibility of delivering 6-treatment cycles of Radium-223 without delays when administered in combination with low-dose oral dexamethasone for patients with metastatic CRPC and bony metastases who are abiraterone, enzalutamide and systemic chemotherapy naïve.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone plus Radium-223 in people with Metastatic Prostate Cancer, run by University Health Network, Toronto 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 17 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Jan 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Percentage of total doses delivered on schedule (time frame: Through infusion completion, an average of 24 weeks). 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 24 Jan 2024.