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

Primary Purpose

Oligometastatic Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hypofractionated external beam radiotherapy
High dose rate brachytherapy
Permanent seed implant
Stereotactic body radiotherapy
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oligometastatic Prostate Cancer focused on measuring prostate adenocarcinoma, oligometastases, radiotherapy, hypofractionation, brachytherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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, Transrectal ultrasound-guided biopsy, CT or MRI abdomen and pelvis, 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

Sites / Locations

  • British Columbia Cancer Agency Center for the Southern InteriorRecruiting
  • Fraser Valley Cancer Center
  • Vancouver Cancer Center
  • Vancouver Island Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

standard

High dose rate brachytherapy

Permanent seed implant brachytherapy

Stereotactic body radiotherapy

Arm Description

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

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

A single permanent implant of radioactive Iodine-125 seeds is performed under anesthesia as an out patient to deliver 125 Gy to the prostate

36.25 Gy is delivered to the prostate in 5 fractions given either weekly or every second day, using a SABR technique.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Expanded Prostate Cancer Index (EPIC) urinary domain
Urinary Quality of life, 0/100 higher score better
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)
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.
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
Distant metastatic failure
Progression free survival measured as time to new or progressive bone metastases
Nodal progression
Progression free survival measured as new or progressive adenopathy on imaging
Overall survival
Overall survival regardless of cause of death
Cause specific survival
Death from prostate cancer
Cost effectiveness
Analysis of primary treatment costs and secondary treatment costs at time of progression

Full Information

First Posted
October 14, 2020
Last Updated
May 19, 2023
Sponsor
British Columbia Cancer Agency
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1. Study Identification

Unique Protocol Identification Number
NCT04610372
Brief Title
5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)
Acronym
PROMPT
Official Title
Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British Columbia Cancer Agency

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligometastatic Prostate Cancer
Keywords
prostate adenocarcinoma, oligometastases, radiotherapy, hypofractionation, brachytherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There is one standard arm (5500/20) and 3 alternative arms. The alternative arms are center (or investigator) specific. Thus, each randomization is 2-way, but with a 3:1 weighting so that the 4 treatment arms have equal numbers of patients.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard
Arm Type
Active Comparator
Arm Description
External beam radiotherapy to deliver 5500 centiGray (cGy) in 20 fractions to the prostate over 4 weeks
Arm Title
High dose rate brachytherapy
Arm Type
Experimental
Arm Description
A single fraction of 19 Gray (Gy) is delivered to the prostate under anesthesia as an out patient.
Arm Title
Permanent seed implant brachytherapy
Arm Type
Experimental
Arm Description
A single permanent implant of radioactive Iodine-125 seeds is performed under anesthesia as an out patient to deliver 125 Gy to the prostate
Arm Title
Stereotactic body radiotherapy
Arm Type
Experimental
Arm Description
36.25 Gy is delivered to the prostate in 5 fractions given either weekly or every second day, using a SABR technique.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated external beam radiotherapy
Intervention Description
5500 cGy/20 fractions delivered 5 days per week over 4 weeks
Intervention Type
Radiation
Intervention Name(s)
High dose rate brachytherapy
Intervention Description
A single fraction of 19 Gy is delivered from an automated afterloading Iridium-192 source via interstitial catheters placed under ultrasound guidance
Intervention Type
Radiation
Intervention Name(s)
Permanent seed implant
Other Intervention Name(s)
Low dose rate brachytherapy
Intervention Description
Iodine-125 radioactive seeds are implanted permanently in the prostate in a single procedure under transrectal ultrasound guidance
Intervention Type
Radiation
Intervention Name(s)
Stereotactic body radiotherapy
Other Intervention Name(s)
SABR
Intervention Description
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 Information:
Title
Urinary symptoms
Description
International Prostate Symptom score (0/35), higher worse
Time Frame
Baseline to 2 years
Secondary Outcome Measure Information:
Title
Expanded Prostate Cancer Index (EPIC) urinary domain
Description
Urinary Quality of life, 0/100 higher score better
Time Frame
Baseline to 2 years
Title
EPIC bowel domain
Description
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
Title
EPIC sexual domain
Description
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
Title
Biochemical failure (time to increase in prostate specific antigen (ng/ml) to 50% > nadir
Description
Progression free survival measured as time to Prostate Specific Antigen (PSA) rise by 50% > nadir
Time Frame
Baseline to 3 years
Title
Distant metastatic failure
Description
Progression free survival measured as time to new or progressive bone metastases
Time Frame
Baseline to 3 years
Title
Nodal progression
Description
Progression free survival measured as new or progressive adenopathy on imaging
Time Frame
Baseline to 3 years
Title
Overall survival
Description
Overall survival regardless of cause of death
Time Frame
3 years
Title
Cause specific survival
Description
Death from prostate cancer
Time Frame
Within 3 years of treatment
Title
Cost effectiveness
Description
Analysis of primary treatment costs and secondary treatment costs at time of progression
Time Frame
3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, Transrectal ultrasound-guided biopsy, CT or MRI abdomen and pelvis, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juanita Crook, MD
Phone
250 712 3958
Email
jcrook@bccancer.bc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juanita Crook, MD
Organizational Affiliation
BCCancer
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Cancer Agency Center for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y5L3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juanita Crook, MD
Phone
250 712 3958
Email
jcrook@bccancer.bc.ca
First Name & Middle Initial & Last Name & Degree
Deidre Batchelar, PhD
First Name & Middle Initial & Last Name & Degree
Cynthia Araujo, PhD
First Name & Middle Initial & Last Name & Degree
David Kim, MD
First Name & Middle Initial & Last Name & Degree
David Petrik, MD
First Name & Middle Initial & Last Name & Degree
Michelle Hilts, PhD
First Name & Middle Initial & Last Name & Degree
Ross Halperin, MD
First Name & Middle Initial & Last Name & Degree
Moore Jocelyn, MD
First Name & Middle Initial & Last Name & Degree
Koulis Theodora, MD
First Name & Middle Initial & Last Name & Degree
Halperin Ross, MD
Facility Name
Fraser Valley Cancer Center
City
Surrey
State/Province
British Columbia
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winkle Kwan, MD
Email
wkwan@bccancer.bc.ca
Facility Name
Vancouver Cancer Center
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mira Keyes, MD
Phone
604-266-6444
Email
mkeyes@bccancer.bc.ca
Facility Name
Vancouver Island Cancer Center
City
Victoria
State/Province
British Columbia
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abe Alexander, MD
Email
AAlexander3@bccancer.bc.ca
First Name & Middle Initial & Last Name & Degree
Saibish Elantholi Parmeswaran, MD
Email
Saibishkumar.ElantholiParmeswaran@bccancer.bc.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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

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