RecruitingNot ApplicableNCT04610372

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

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

Sponsor

British Columbia Cancer Agency

Enrollment

168 participants

Start Date

Jul 12, 2021

Study Type

INTERVENTIONAL

Conditions

Oligometastatic Prostate Cancer

Summary

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria10

Able to provide informed consent
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 Criteria10

High metastatic burden defined as 5 or more bone metastases or visceral metastases
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

Interventions

RADIATIONHypofractionated external beam radiotherapy

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

RADIATIONHigh 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

RADIATIONPermanent seed implant

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

RADIATIONStereotactic 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.