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

Oligometastatic Prostate Cancer Clinical Trial

— PROMPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610372
• Other study ID #: H20-01207
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: January 2026

Study information

• Verified date: December 2023
• Source: British Columbia Cancer Agency
• Contact: Juanita Crook, MD
• Phone: 250 712 3958
• Email: jcrook[@]bccancer.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists must have started within 24 weeks of randomization

• If used, anti-androgens must have started within 26 weeks of randomization

• Able to complete the necessary investigations prior to and within 12 weeks of starting Androgen Deprivation Therapy (ADT) or of randomization (History and physical examination, PSA)

• Able to complete the necessary investigations priOr to start of Radiotherapy (Transrectal ultrasound-guided biopsy, CT chest, abdomen & pelvis or MRI abdomen and pelvis, and Bone scan)

• Planned for long-term androgen deprivation therapy

Exclusion Criteria:

• 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

• Medically unfit for anesthesia

• International Prostate Symptom Score (IPSS) greater than 20

• Restrictive flow pattern 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

Related Conditions & MeSH terms

• Oligometastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency Center for the Southern Interior	Kelowna	British Columbia
Canada	Fraser Valley Cancer Center	Surrey	British Columbia
Canada	Vancouver Cancer Center	Vancouver	British Columbia
Canada	Vancouver Island Cancer Center	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary symptoms	International Prostate Symptom score (0/35), higher worse	Baseline to 2 years
Secondary	Expanded Prostate Cancer Index (EPIC) urinary domain	Urinary Quality of life, 0/100 higher score better	Baseline to 2 years
Secondary	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)	Baseline to 2 years
Secondary	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.	Baseline to 2 years
Secondary	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	Baseline to 3 years
Secondary	Distant metastatic failure	Progression free survival measured as time to new or progressive bone metastases	Baseline to 3 years
Secondary	Nodal progression	Progression free survival measured as new or progressive adenopathy on imaging	Baseline to 3 years
Secondary	Overall survival	Overall survival regardless of cause of death	3 years
Secondary	Cause specific survival	Death from prostate cancer	Within 3 years of treatment
Secondary	Cost effectiveness	Analysis of primary treatment costs and secondary treatment costs at time of progression	3 years