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

ConditionOligometastatic Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorBritish Columbia Cancer Agency

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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.

Treatment groups

168 Participants
are divided into 4 treatment groups
Group A: standardActive comparator 1 intervention
Group B: High dose rate brachytherapyExperimental treatment 1 intervention
Group C: Permanent seed implant brachytherapyExperimental treatment 1 intervention
Group D: Stereotactic body radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Urinary symptoms

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

Time frame
Baseline to 2 years

Secondary outcomes

1

Expanded Prostate Cancer Index (EPIC) urinary domain

Urinary Quality of life, 0/100 higher score better

Time frame
Baseline to 2 years
2

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)

Time frame
Baseline to 2 years
3

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.

Time frame
Baseline to 2 years
4

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

Time frame
Baseline to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

British Columbia Cancer Agency

Lead sponsor

Source ClinicalTrials.gov
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