Oligometastatic Prostate CancerPROMPTNCT04610372
5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)
A study testing Hypofractionated external beam radiotherapy, High dose rate brachytherapy and Permanent seed implant in people with Oligometastatic Prostate Cancer, run by British Columbia Cancer Agency at 4 sites in Canada.
Trial summary
We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Oligometastatic Prostate Cancer
- What is being tested?
- Hypofractionated external beam radiotherapy, High dose rate brachytherapy and Permanent seed implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 4 sitesCanada
- Study dates
- 12 Jul 2021to 30 Jun 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Signed study specific informed consent
- European Cooperative Oncology Group performance status 0 to 2
- Histologically confirmed adenocarcinoma of the prostate
- Any Tumor stage, any T, any N, M1
- No prior therapy for prostate cancer apart from androgen deprivation
- Planned for long-term androgen deprivation therapy (greater than 9 months in duration)
- Patient is able and willing to complete the quality of life questionnaires, and other assessments that are a part of this study
- For brachytherapy arms, patient must be technically suitable for brachytherapy according to investigator, in terms of bladder function and prostate size.
Who cannot join
- High metastatic burden defined as 5 or more bone metastases or visceral metastases
- Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation
- For Brachytherapy Arms =: Any prior Transurethral resection of prostate
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
British Columbia Cancer Agency Center for the Southern Interior
Kelowna, British Columbia, V1Y5L3
Juanita Crook, MD, 250 712 3958, jcrook@bccancer.bc.ca
Deidre Batchelar, PhD
- Not yet recruiting
Fraser Valley Cancer Center
Surrey, British Columbia
Winkle Kwan, MD, wkwan@bccancer.bc.ca
- Recruiting
Vancouver Cancer Center
Vancouver, British Columbia
Raman Srinivas, MD, 604-877-6000, srinivas.raman@bccancer.bc.ca
Srinivas Raman, MD
- Recruiting
Vancouver Island Cancer Center
Victoria, British Columbia
Saibishkumar Elantholi Parmeswaran, MD, skumar@bccancer.bc.ca
Jordan Wong, MD
About this study
Official title: Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment
We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.
Read the detailed description
Men newly diagnosed with low volume oligometastatic prostate cancer defined as fewer than 5 bone metastases and/or non regional lymph node involvement who agree to treatment of the primary cancer with radiation will be randomized between standard moderately hypofractionated external radiotherapy (5500 centiGray/20 fractions as per Stampede trial) and one of 3 alternatives: stereotactic body radiotherapy (SABR) to deliver 36 Gy/5 fractions, or low dose rate Iodine 125 permanent seed implant or a single high dose rate temporary implant. The trial will take place in 4 regional cancer centers of British Columbia Cancer Agency, with each center choosing their preferred alternative to 5500/20. To achieve 4 equally sized treatment arms, each randomization is weighted 3:1 for 42 patients in each arm and 168 total accrual. The primary endpoint is urinary quality of life as assessed by the International Prostate Symptom Score (IPSS) . As the typical acute symptoms from each of these radiation modalities has a unique time course, assessments are done at 6 different points during the first 2 years. Secondary endpoints are global quality of life as assessed by Expanded Prostate Cancer Index (EPIC) urinary, bowel and sexual scores, progression free survival, overall survival and cost effectiveness.
- Conditions
- Oligometastatic Prostate Cancer
- Being tested
- Hypofractionated external beam radiotherapy, High dose rate brachytherapy, Permanent seed implant, Stereotactic body radiotherapy
- Keywords
- prostate adenocarcinoma, oligometastases, radiotherapy, hypofractionation, brachytherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated external beam radiotherapyRadiation
5500 cGy/20 fractions delivered 5 days per week over 4 weeks
High dose rate brachytherapyRadiation
A single fraction of 19 Gy is delivered from an automated afterloading Iridium-192 source via interstitial catheters placed under ultrasound guidance
Permanent seed implantRadiation
Also called Low dose rate brachytherapy
Iodine-125 radioactive seeds are implanted permanently in the prostate in a single procedure under transrectal ultrasound guidance
Stereotactic body radiotherapyRadiation
Also called SABR
External radiation using SABR technology delivers 36.25 Gy to the prostate in 5 fractions given either once weekly for 5 weeks or every second day over 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| standard | Active comparator | External beam radiotherapy to deliver 5500 centiGray (cGy) in 20 fractions to the prostate over 4 weeks Receives: Radiation: Hypofractionated external beam radiotherapy |
| High dose rate brachytherapy | Experimental | A single fraction of 19 Gray (Gy) is delivered to the prostate under anesthesia as an out patient. Receives: Radiation: High dose rate brachytherapy |
| Permanent seed implant brachytherapy | Experimental | A single permanent implant of radioactive Iodine-125 seeds is performed under anesthesia as an out patient to deliver 125 Gy to the prostate Receives: Radiation: Permanent seed implant |
| Stereotactic body radiotherapy | Experimental | 36.25 Gy is delivered to the prostate in 5 fractions given either weekly or every second day, using a SABR technique. Receives: Radiation: Stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary symptoms
International Prostate Symptom score (0/35), higher worse
Measured: Baseline to 2 years
Secondary outcomes (9)
Expanded Prostate Cancer Index (EPIC) urinary domain
Urinary Quality of life, 0/100 higher score better
Measured: Baseline to 2 years
EPIC bowel domain
Bowel quality of life, 0/100, higher score better. Series of validated questions concerning urgency, frequency, consistency, leakage, presence of blood and pain with bowel movements and then rates how big a problem each symptom was (0-5)
Measured: Baseline to 2 years
EPIC sexual domain
Sexual quality of life, 0/100, higher score better. Series of validated questions concerning frequency and quality of erections, presence of morning erections, ability to engage in sexual activity or intercourse, rates ability and then rates importance of each issue to the patient.
Measured: Baseline to 2 years
Biochemical failure (time to increase in prostate specific antigen (ng/ml) to 50% > nadir
Progression free survival measured as time to Prostate Specific Antigen (PSA) rise by 50% > nadir
Measured: Baseline to 3 years
Distant metastatic failure
Progression free survival measured as time to new or progressive bone metastases
Measured: Baseline to 3 years
Nodal progression
Progression free survival measured as new or progressive adenopathy on imaging
Measured: Baseline to 3 years
Overall survival
Overall survival regardless of cause of death
Measured: 3 years
Cause specific survival
Death from prostate cancer
Measured: Within 3 years of treatment
Cost effectiveness
Analysis of primary treatment costs and secondary treatment costs at time of progression
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start12 Jul 2021
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There is one standard arm (5500/20) and 3 alternative arms. The alternative arms are selected at the treating center. Thus, each randomization is 2-way, but with a 3:1 weighting so that the 4 treatment arms have equal numbers of patients.
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juanita Crook, British Columbia Cancer Agency
- Investigators
- Juanita Crook, MD, Principal investigator, BCCancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610372
- Sponsor's protocol ID
- H20-01207
- Acronym
- PROMPT
- Status last verified
- Apr 2026
- First submitted
- 14 Oct 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment
- ClinicalTrials.gov ID
- NCT04610372
- Acronym / sponsor ID
- PROMPT / H20-01207
- Conditions
- Oligometastatic Prostate Cancer
- Keywords
- prostate adenocarcinoma, oligometastases, radiotherapy, hypofractionation, brachytherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 30 Oct 2020 (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.
We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.
Detailed description
Men newly diagnosed with low volume oligometastatic prostate cancer defined as fewer than 5 bone metastases and/or non regional lymph node involvement who agree to treatment of the primary cancer with radiation will be randomized between standard moderately hypofractionated external radiotherapy (5500 centiGray/20 fractions as per Stampede trial) and one of 3 alternatives: stereotactic body radiotherapy (SABR) to deliver 36 Gy/5 fractions, or low dose rate Iodine 125 permanent seed implant or a single high dose rate temporary implant. The trial will take place in 4 regional cancer centers of British Columbia Cancer Agency, with each center choosing their preferred alternative to 5500/20. To achieve 4 equally sized treatment arms, each randomization is weighted 3:1 for 42 patients in each arm and 168 total accrual. The primary endpoint is urinary quality of life as assessed by the International Prostate Symptom Score (IPSS) . As the typical acute symptoms from each of these radiation modalities has a unique time course, assessments are done at 6 different points during the first 2 years. Secondary endpoints are global quality of life as assessed by Expanded Prostate Cancer Index (EPIC) urinary, bowel and sexual scores, progression free survival, overall survival and cost effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There is one standard arm (5500/20) and 3 alternative arms. The alternative arms are selected at the treating center. Thus, each randomization is 2-way, but with a 3:1 weighting so that the 4 treatment arms have equal numbers of patients.
| Arm | Type | Receives |
|---|---|---|
| standard | Active comparator | Radiation: Hypofractionated external beam radiotherapyExternal beam radiotherapy to deliver 5500 centiGray (cGy) in 20 fractions to the prostate over 4 weeks |
| High dose rate brachytherapy | Experimental | Radiation: High dose rate brachytherapyA single fraction of 19 Gray (Gy) is delivered to the prostate under anesthesia as an out patient. |
| Permanent seed implant brachytherapy | Experimental | Radiation: Permanent seed implantA single permanent implant of radioactive Iodine-125 seeds is performed under anesthesia as an out patient to deliver 125 Gy to the prostate |
| Stereotactic body radiotherapy | Experimental | Radiation: Stereotactic body radiotherapy36.25 Gy is delivered to the prostate in 5 fractions given either weekly or every second day, using a SABR technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed study specific informed consent
- European Cooperative Oncology Group performance status 0 to 2
- Histologically confirmed adenocarcinoma of the prostate
- Any Tumor stage, any T, any N, M1
- No prior therapy for prostate cancer apart from androgen deprivation
Key exclusion criteria (3 listed)
- High metastatic burden defined as 5 or more bone metastases or visceral metastases
- Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation
- For Brachytherapy Arms =: Any prior Transurethral resection of prostate
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 |
|---|---|---|
| Hypofractionated external beam radiotherapy5500 cGy/20 fractions delivered 5 days per week over 4 weeks | Radiation | standard |
| High dose rate brachytherapyA single fraction of 19 Gy is delivered from an automated afterloading Iridium-192 source via interstitial catheters placed under ultrasound guidance | Radiation | High dose rate brachytherapy |
| Permanent seed implantAlso: Low dose rate brachytherapyIodine-125 radioactive seeds are implanted permanently in the prostate in a single procedure under transrectal ultrasound guidance | Radiation | Permanent seed implant brachytherapy |
| Stereotactic body radiotherapyAlso: SABRExternal radiation using SABR technology delivers 36.25 Gy to the prostate in 5 fractions given either once weekly for 5 weeks or every second day over 2 weeks. | Radiation | Stereotactic body radiotherapy |
Primary outcome
Urinary symptoms
Time frame: Baseline to 2 years
International Prostate Symptom score (0/35), higher worse
9 secondary outcomes
Expanded Prostate Cancer Index (EPIC) urinary domain
Time frame: Baseline to 2 years
EPIC bowel domain
Time frame: Baseline to 2 years
EPIC sexual domain
Time frame: Baseline to 2 years
Biochemical failure (time to increase in prostate specific antigen (ng/ml) to 50% > nadir
Time frame: Baseline to 3 years
Distant metastatic failure
Time frame: Baseline to 3 years
Nodal progression
Time frame: Baseline to 3 years
Overall survival
Time frame: 3 years
Cause specific survival
Time frame: Within 3 years of treatment
Cost effectiveness
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- 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.
Juanita Crook, MD principal investigator
BCCancer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated external beam radiotherapy, High dose rate brachytherapy and Permanent seed implant in people with Oligometastatic Prostate Cancer, run by British Columbia Cancer Agency at 4 sites 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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juanita Crook, MD (250 712 3958, jcrook@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary symptoms (time frame: Baseline to 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 6 May 2026.