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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Canada
British Columbia Cancer Agency Center for the Southern Interior
RECRUITING
Kelowna
Fraser Valley Cancer Center
NOT_YET_RECRUITING
Surrey
Vancouver Cancer Center
NOT_YET_RECRUITING
Vancouver
Vancouver Island Cancer Center
RECRUITING
Victoria
Contact Information
Primary
Juanita Crook, MD
jcrook@bccancer.bc.ca
250 712 3958
Time Frame
Start Date: 2021-07-12
Estimated Completion Date: 2033-06-30
Participants
Target number of participants: 168
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: British Columbia Cancer Agency

This content was sourced from clinicaltrials.gov