Hormone Sensitive Oligometastatic Prostate CancerPRORADNCT03301701
Feasibility Trial in Men With Hormone Sensitive Oligometastatic Prostate Cancer
A study testing Radical prostatectomy and HDR (19Gy) or SBRT (35-40Gy) in people with Hormone Sensitive Oligometastatic Prostate Cancer, run by Dr. Patrick Cheung at 1 site in Canada.
Trial summary
Patients with hormone sensitive oligometastatic prostate cancer (≤ 5 metastatic tumours outside of regional pelvic nodes with no more than 3 in any organ system) and no previous treatment to prostate will be treated with intermittent androgen deprivation therapy +/- chemotherapy, stereotactic radiotherapy to all… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone Sensitive Oligometastatic Prostate Cancer
- What is being tested?
- Radical prostatectomy and HDR (19Gy) or SBRT (35-40Gy)
- 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
- 22 Sep 2017to 30 May 2019
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent.
- Histologic confirmation of prostate adenocarcinoma.
- Stage IV disease with ≤ 5 metastases outside of the pelvis.
- ≤ 3 metastases in any one organ system.
- ECOG performance 0-1.
- All metastatic tumours amenable to SBRT.
- Patient eligible for either RP or RT to the prostate.
Who cannot join
- Castration resistant prostate cancer.
- Previous RP or RT to prostate.
- Inability to treat all metastases with SBRT.
- Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, in-situ cancer, superficial bladder cancer, chronic lymphocytic leukemia or low grade lymphoma which is being observed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Feasibility Trial of Prostate Radiotherapy vs Prostatectomy in Men With Hormone Sensitive Oligometastatic Prostate Cancer
Patients with hormone sensitive oligometastatic prostate cancer (≤ 5 metastatic tumours outside of regional pelvic nodes with no more than 3 in any organ system) and no previous treatment to prostate will be treated with intermittent androgen deprivation therapy +/- chemotherapy, stereotactic radiotherapy to all metastases, and either radical prostatectomy or radiotherapy.
Read the detailed description
Investigators propose to do a randomized feasibility trial comparing RP vs RT to the prostate in the setting of hormone sensitive oligometastatic prostate cancer. SBRT will be used to treat all of the metastases, and this will be combined with an intermittent ADT approach. Adding systemic chemotherapy will be allowed. Given the past difficulties of randomizing patients between RP and RT in localized prostate cancer studies (like SPIRIT), investigators feel a small feasibility project is the first step. In the setting of metastatic disease, where radical treatment is not routine standard of care, we hope that patients will be more inclined to accept randomization. If patients do not accept their assigned randomization (ie they prefer RP even though they are randomized to RT, or vice versa), they will still be treated with their prostate intervention of choice and followed for their outcomes.
- Being tested
- Radical prostatectomy, HDR (19Gy) or SBRT (35-40Gy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical prostatectomyProcedure or surgery
Radical prostatectomy
HDR (19Gy) or SBRT (35-40Gy)Radiation
Patients will receive HDR unless judged to medically unfit to undergo HDR brachytherapy, in which case they will receive SBRT
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Radical prostatectomy Receives: Procedure: Radical prostatectomy |
| Arm 2 | Active comparator | Radiotherapy Receives: Radiation: HDR (19Gy) or SBRT (35-40Gy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients willing to accept their randomization
Patients willing to accept their randomization will be measured as a proportion.
Measured: 2 years
Secondary outcomes (6)
Toxicity
Acute and late toxicities will be measured using CTCAE v4.0 and will be reported as percentages.
Measured: 7 years
Efficacy
Time to CRPC will be calculated using Kaplan Meier methodology.
Measured: 7 years
Efficacy
Progression free survival will be calculated using Kaplan Meier methodology.
Measured: 7 years
Efficacy
Local control will be calculated using Kaplan Meier methodology.
Measured: 7 years
Efficacy
Distant control will be calculated using Kaplan Meier methodology.
Measured: 7 years
Efficacy
Overall survival will be calculated using Kaplan Meier methodology.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start22 Sep 2017
- Primary completion30 May 2019
- Study completion30 May 2019
Why it stopped: Lack of accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Sensitive Oligometastatic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Patrick Cheung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Patrick Cheung, Sunnybrook Health Sciences Centre
- Investigators
- Patrick Cheung, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301701
- Sponsor's protocol ID
- PRORAD
- Acronym
- PRORAD
- Status last verified
- Nov 2020
- First submitted
- 11 Jan 2017
- Last updated
- 1 Dec 2020
- 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 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Feasibility Trial of Prostate Radiotherapy vs Prostatectomy in Men With Hormone Sensitive Oligometastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT03301701
- Acronym / sponsor ID
- PRORAD / PRORAD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of accruals
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dr. Patrick CheungUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 4 Oct 2017 (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.
Patients with hormone sensitive oligometastatic prostate cancer (≤ 5 metastatic tumours outside of regional pelvic nodes with no more than 3 in any organ system) and no previous treatment to prostate will be treated with intermittent androgen deprivation therapy +/- chemotherapy, stereotactic radiotherapy to all metastases, and either radical prostatectomy or radiotherapy.
Detailed description
Investigators propose to do a randomized feasibility trial comparing RP vs RT to the prostate in the setting of hormone sensitive oligometastatic prostate cancer. SBRT will be used to treat all of the metastases, and this will be combined with an intermittent ADT approach. Adding systemic chemotherapy will be allowed. Given the past difficulties of randomizing patients between RP and RT in localized prostate cancer studies (like SPIRIT), investigators feel a small feasibility project is the first step. In the setting of metastatic disease, where radical treatment is not routine standard of care, we hope that patients will be more inclined to accept randomization. If patients do not accept their assigned randomization (ie they prefer RP even though they are randomized to RT, or vice versa), they will still be treated with their prostate intervention of choice and followed for their outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: Radical prostatectomyRadical prostatectomy |
| Arm 2 | Active comparator | Radiation: HDR (19Gy) or SBRT (35-40Gy)Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to provide informed consent.
- Histologic confirmation of prostate adenocarcinoma.
- Stage IV disease with ≤ 5 metastases outside of the pelvis.
- ≤ 3 metastases in any one organ system.
- ECOG performance 0-1.
Key exclusion criteria (4 listed)
- Castration resistant prostate cancer.
- Previous RP or RT to prostate.
- Inability to treat all metastases with SBRT.
- Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, in-situ cancer, superficial bladder cancer, chronic lymphocytic leukemia or low grade lymphoma which is being observed.
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 |
|---|---|---|
| Radical prostatectomyRadical prostatectomy | Procedure or surgery | Arm 1 |
| HDR (19Gy) or SBRT (35-40Gy)Patients will receive HDR unless judged to medically unfit to undergo HDR brachytherapy, in which case they will receive SBRT | Radiation | Arm 2 |
Primary outcome
Patients willing to accept their randomization
Time frame: 2 years
Patients willing to accept their randomization will be measured as a proportion.
6 secondary outcomes
Toxicity
Time frame: 7 years
Efficacy
Time frame: 7 years
Efficacy
Time frame: 7 years
Efficacy
Time frame: 7 years
Efficacy
Time frame: 7 years
Efficacy
Time frame: 7 years
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 1 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Hormone Sensitive Oligometastatic Prostate Cancer
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Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
PSA Level Greater Than Two, Stage IV Prostate Adenocarcinoma AJCC v7
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[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer
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Prospective Study on the Role of Radical Prostatectomy in Oligo-metastatic Hormone-sensitive Prostate Cancer in Patients on Androgen Deprivation Therapy
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Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer
Prostate Cancer
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.
Patrick Cheung principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical prostatectomy and HDR (19Gy) or SBRT (35-40Gy) in people with Hormone Sensitive Oligometastatic Prostate Cancer, run by Dr. Patrick Cheung 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 7 inclusion and 4 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 1 Dec 2020. 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.
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?
Patients willing to accept their randomization (time frame: 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 1 Dec 2020.