5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)
NCT ID: NCT04610372
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
168 participants
INTERVENTIONAL
2021-07-12
2033-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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standard
External beam radiotherapy to deliver 5500 centiGray (cGy) in 20 fractions to the prostate over 4 weeks
Hypofractionated external beam radiotherapy
5500 cGy/20 fractions delivered 5 days per week over 4 weeks
High dose rate brachytherapy
A single fraction of 19 Gray (Gy) is delivered to the prostate under anesthesia as an out patient.
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
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
Permanent seed implant
Iodine-125 radioactive seeds are implanted permanently in the prostate in a single procedure under transrectal ultrasound guidance
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.
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.
Interventions
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Hypofractionated external beam radiotherapy
5500 cGy/20 fractions delivered 5 days per week over 4 weeks
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
Permanent seed implant
Iodine-125 radioactive seeds are implanted permanently in the prostate in a single procedure under transrectal ultrasound guidance
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* European Cooperative Oncology Group performance status 0 to 2
* Medically fit for all protocol treatment and follow-up
* Histologically confirmed adenocarcinoma of the prostate
* Newly diagnosed any Tumor stage, any Nodal stage but with oligo metastases
* No prior therapy for prostate cancer apart from androgen deprivation
* Able to complete the necessary investigations prior to randomization (History and physical examination, PSA)
* Able to complete the necessary investigations prior to start of Radiotherapy (Transrectal ultrasound-guided biopsy or equivalent, CT chest, abdomen \& pelvis or MRI abdomen and pelvis, and Bone scan)
* 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
Exclusion Criteria
* Abnormal liver function
* Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation
Contraindications to brachytherapy including:
* Medically unfit for anesthesia,
* International Prostate Symptom Score (IPSS) greater than 20
* Poor urinary flow with peak flow rate less than10 mL per second or post-void residual greater than 25 per cent of voided volume (when uroflowmetry available)
* Prostate volume greater than 60cc after maximal cytoreduction
* Pubic arch interference
* Transurethral resection of prostate (TURP) within 12 weeks of brachytherapy
18 Years
MALE
No
Sponsors
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British Columbia Cancer Agency
OTHER
Responsible Party
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Juanita Crook
Professor of Radiation Oncology
Principal Investigators
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Juanita Crook, MD
Role: PRINCIPAL_INVESTIGATOR
BCCancer
Locations
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British Columbia Cancer Agency Center for the Southern Interior
Kelowna, British Columbia, Canada
Fraser Valley Cancer Center
Surrey, British Columbia, Canada
Vancouver Cancer Center
Vancouver, British Columbia, Canada
Vancouver Island Cancer Center
Victoria, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H20-01207
Identifier Type: -
Identifier Source: org_study_id
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