Recruiting

5500/20 vs. SABR

Sponsor:

British Columbia Cancer Agency

Code:

NCT04610372

Conditions

Oligometastatic Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypofractionated external beam radiotherapy

High dose rate brachytherapy

Permanent seed implant

Stereotactic body radiotherapy

Study Details

Brief 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.

Conditions

Oligometastatic Prostate Cancer

Study ID

NCT04610372

Start date

Jul 12, 2021

Status verified date

Apr, 2026

Completion date

Jun 30, 2033

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: standard

External beam radiotherapy to deliver 5500 centiGray (cGy) in 20 fractions to the prostate over 4 weeks

experimental: High dose rate brachytherapy

A single fraction of 19 Gray (Gy) is delivered to the prostate under anesthesia as an out patient.

experimental: 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

experimental: 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.

Interventions

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.

Primary outcome measure

  • Urinary symptoms [ Time Frame: Baseline to 2 years ]

Central Contacts and Locations

Central contacts

Juanita Crook, MD

250 712 3958jcrook@bccancer.bc.ca

Locations

British Columbia Cancer Agency Center for the Southern Interior

Recruiting

Kelowna, British Columbia, Canada, V1Y5L3

Contacts

Juanita Crook, MD

250 712 3958jcrook@bccancer.bc.ca

Principal Investigator:

Juanita Crook, MD

Vancouver Cancer Center

Recruiting

Vancouver, British Columbia, Canada

Contacts

Raman Srinivas, MD

604-877-6000srinivas.raman@bccancer.bc.ca

Principal Investigator:

Srinivas Raman, MD

Vancouver Island Cancer Center

Recruiting

Victoria, British Columbia, Canada

Contacts

Saibishkumar Elantholi Parmeswaran, MD

skumar@bccancer.bc.ca

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • prostate adenocarcinoma
  • oligometastases
  • radiotherapy
  • hypofractionation
  • brachytherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2026-05-06.