5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT) (PROMPT)

April 30, 2026 updated by: Juanita Crook, British Columbia Cancer Agency

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y5L3
        • Recruiting
        • British Columbia Cancer Agency Center for the Southern Interior
        • Principal Investigator:
          • Juanita Crook, MD
        • Sub-Investigator:
          • David Kim, MD
        • Contact:
        • Sub-Investigator:
          • Deidre Batchelar, PhD
        • Sub-Investigator:
          • Cynthia Araujo, PhD
        • Sub-Investigator:
          • Ross Halperin, MD
        • Sub-Investigator:
          • Hamid Raziee, MD
      • Surrey, British Columbia, Canada
        • Not yet recruiting
        • Fraser Valley Cancer Center
        • Contact:
      • Vancouver, British Columbia, Canada
        • Recruiting
        • Vancouver Cancer Center
        • Principal Investigator:
          • Srinivas Raman, MD
        • Contact:
      • Victoria, British Columbia, Canada
        • Recruiting
        • Vancouver Island Cancer Center
        • Contact:
        • Sub-Investigator:
          • Jordan Wong, MD
        • Sub-Investigator:
          • Jonathan Livergant, MD
        • Sub-Investigator:
          • Howard Pai, MD
        • Sub-Investigator:
          • Abe Alexander, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: standard
External beam radiotherapy to deliver 5500 centiGray (cGy) in 20 fractions to the prostate over 4 weeks
Radiation: Hypofractionated external beam radiotherapy
5500 cGy/20 fractions delivered 5 days per week over 4 weeks
Experimental: High dose rate brachytherapy
A single fraction of 19 Gray (Gy) is delivered to the prostate under anesthesia as an out patient.
Radiation: High dose rate brachytherapy
A single fraction of 19 Gy is delivered from an automated afterloading Iridium-192 source via interstitial catheters placed under ultrasound guidance
Experimental: Permanent seed implant brachytherapy
A single permanent implant of radioactive Iodine-125 seeds is performed under anesthesia as an out patient to deliver 125 Gy to the prostate
Radiation: Permanent seed implant
Iodine-125 radioactive seeds are implanted permanently in the prostate in a single procedure under transrectal ultrasound guidance
Other Names:
  • Low dose rate brachytherapy
Experimental: Stereotactic body radiotherapy
36.25 Gy is delivered to the prostate in 5 fractions given either weekly or every second day, using a SABR technique.
Radiation: Stereotactic body radiotherapy
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.
Other Names:
  • SABR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Urinary symptoms
Time Frame: Baseline to 2 years
International Prostate Symptom score (0/35), higher worse
Baseline to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Expanded Prostate Cancer Index (EPIC) urinary domain
Time Frame: Baseline to 2 years
Urinary Quality of life, 0/100 higher score better
Baseline to 2 years
EPIC bowel domain
Time Frame: Baseline to 2 years
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)
Baseline to 2 years
EPIC sexual domain
Time Frame: Baseline to 2 years
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.
Baseline to 2 years
Biochemical failure (time to increase in prostate specific antigen (ng/ml) to 50% > nadir
Time Frame: Baseline to 3 years
Progression free survival measured as time to Prostate Specific Antigen (PSA) rise by 50% > nadir
Baseline to 3 years
Distant metastatic failure
Time Frame: Baseline to 3 years
Progression free survival measured as time to new or progressive bone metastases
Baseline to 3 years
Nodal progression
Time Frame: Baseline to 3 years
Progression free survival measured as new or progressive adenopathy on imaging
Baseline to 3 years
Overall survival
Time Frame: 3 years
Overall survival regardless of cause of death
3 years
Cause specific survival
Time Frame: Within 3 years of treatment
Death from prostate cancer
Within 3 years of treatment
Cost effectiveness
Time Frame: 3 years
Analysis of primary treatment costs and secondary treatment costs at time of progression
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
British Columbia Cancer Agency

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juanita Crook, MD, BCCancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H20-01207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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