5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypofractionated external beam radiotherapy, High dose rate brachytherapy, Permanent seed implant, Stereotactic body radiotherapy.
- Who it may be relevant to
- Registry conditions: Oligometastatic Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment
Overview
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.
Interventions
- Radiation Hypofractionated external beam radiotherapy
5500 cGy/20 fractions delivered 5 days per week over 4 weeks - 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 - Radiation Permanent seed implant
Iodine-125 radioactive seeds are implanted permanently in the prostate in a single procedure under transrectal ultrasound guidance - 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.
Primary outcome measures
- Urinary symptoms [Time frame: Baseline to 2 years]
Secondary outcome measures (9)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 4 centers
- British Columbia Cancer Agency Center for the Southern Interior — Kelowna
- Fraser Valley Cancer Center — Surrey
- Vancouver Cancer Center — Vancouver
- Vancouver Island Cancer Center — Victoria
Identifiers
NCT: NCT04610372 · H20-01207