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NCT Number: NCT04610372

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

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.

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Key information

Conditions

Oligometastatic Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Cancer Agency Center for the Southern Interior, Kelowna, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypofractionated external beam radiotherapy

Radiation

5500 cGy/20 fractions delivered 5 days per week over 4 weeks

High dose rate brachytherapy

Radiation

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

Radiation

Iodine-125 radioactive seeds are implanted permanently in the prostate in a single procedure under transrectal ultrasound guidance

Other names: Low dose rate brachytherapy

stereotactic body radiotherapy

Radiation

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

Primary outcomes

  1. Urinary symptoms

    Time frame: Baseline to 2 years

    International Prostate Symptom score (0/35), higher worse

Secondary outcomes

  1. Expanded Prostate Cancer Index (EPIC) urinary domain

    Time frame: Baseline to 2 years

    Urinary Quality of life, 0/100 higher score better

  2. 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)

  3. 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.

  4. 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

  5. Distant metastatic failure

    Time frame: Baseline to 3 years

    Progression free survival measured as time to new or progressive bone metastases

  6. Nodal progression

    Time frame: Baseline to 3 years

    Progression free survival measured as new or progressive adenopathy on imaging

  7. Overall survival

    Time frame: 3 years

    Overall survival regardless of cause of death

  8. Cause specific survival

    Time frame: Within 3 years of treatment

    Death from prostate cancer

  9. Cost effectiveness

    Time frame: 3 years

    Analysis of primary treatment costs and secondary treatment costs at time of progression

Study contacts

Contact information is provided by the study sponsor or research team.

Juanita Crook, MD

CONTACT

[email protected]

250 712 3958

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Official study title

Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment

Acronym: PROMPT

Important dates

Study start
2021
Primary completion
2030
Study completion
2033
First posted
Oct 30, 2020
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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