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Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer (ARTIA-Prostate)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily adaptive SBRT with urethral sparing
Sponsored by
Varian, a Siemens Healthineers Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria: Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven. Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy. AUA/IPSS score is ≤ 15. ECOG performance status is ≤2 (or Karnofsky score is ≥60%). Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion). Patient has the ability to complete required patient questionnaires. Patient age ≥ 18 years (or greater than the local age of majority). Patient has the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patient has baseline grade ≥3 GI or GU toxicity Patient has had prior overlapping pelvic radiotherapy. Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation. Patient has node positive prostate cancer. Patient has extracapsular extension (capsular abutment is permitted). Patient has active inflammatory bowel disease or active collagen vascular disease. Patient cannot undergo prostate MRI. Patient cannot undergo prostate fiducial marker placement. Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).

Sites / Locations

  • Brigham and Women's HospitalRecruiting
  • Fox Chase Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adaptive SBRT with Urethral Sparing

Arm Description

Daily adaptive stereotactic body radiation therapy delivering 40 Gy in 5 fractions to the prostate while delivery 35-36 Gy in 5 fractions to the urethra.

Outcomes

Primary Outcome Measures

Patient-reported acute urinary toxicity
Minimum clinically important change (MCIC) status in patient-reported urinary QOL, as determined by the worst change reported by each subject in their EPIC-26 urinary domain scores.

Secondary Outcome Measures

Freedom from biochemical recurrence
Rate of biochemical recurrence free survival, as determined by the Phoenix definition (PSA level of 2 ng/ml or more higher than the lowest post-SBRT value)
Patient-reported quality of life issues related to prostate cancer.
Patient-reported quality of life changes during and after adaptive prostate SBRT treatment using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) questionnaire.
Patient-reported erectile dysfunction symptoms
Patient-reported erectile dysfunction symptoms before, during and after adaptive prostate SBRT treatment using the Sexual Health Inventory for Men (SHIM) questionnaire.
Patient-reported urinary symptoms
Patient-reported urinary symptoms before, during and after adaptive prostate SBRT treatment using the International Prostate Symptom Score (IPSS) questionnaire.
Patient-reported overall quality of life
Patient-reported overall quality of life before, during and after adaptive prostate SBRT treatment using the EQ-5D-5L questionnaire.
Physician-reported toxicities
Physician-reported CTCAE v 5.0 adverse events
Alpha-blocker medication use
Change in use of alpha-blocker medications for urinary symptoms
Metastasis-free survival
Metastasis-free survival
Prostate-cancer specific mortality
Prostate-cancer specific mortality
Overall survival
Overall survival
Workflow metrics of adaptive SBRT for prostate cancer
Includes the time on table and frequency of using the adapted vs. non-adapted treatment plan for each fraction.
Target and OAR dosimetry
Improvement in target coverage and/or reduction in dose to critical organs at risk in the adapted plan compared to the non-adaptive planned dosimetry
Impact of rectal spacers
Physician reported toxicity and patient reported outcomes with or without implanted resorbable rectal spacer

Full Information

First Posted
March 10, 2023
Last Updated
September 5, 2023
Sponsor
Varian, a Siemens Healthineers Company
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1. Study Identification

Unique Protocol Identification Number
NCT05804318
Brief Title
Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
Acronym
ARTIA-Prostate
Official Title
Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Varian, a Siemens Healthineers Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adaptive SBRT with Urethral Sparing
Arm Type
Experimental
Arm Description
Daily adaptive stereotactic body radiation therapy delivering 40 Gy in 5 fractions to the prostate while delivery 35-36 Gy in 5 fractions to the urethra.
Intervention Type
Device
Intervention Name(s)
Daily adaptive SBRT with urethral sparing
Intervention Description
The radiation plan for each daily fraction is adapted from the initial plan based on cone beam CT imaging acquired while the participant is laying on the treatment machine.
Primary Outcome Measure Information:
Title
Patient-reported acute urinary toxicity
Description
Minimum clinically important change (MCIC) status in patient-reported urinary QOL, as determined by the worst change reported by each subject in their EPIC-26 urinary domain scores.
Time Frame
90 days after end of SBRT
Secondary Outcome Measure Information:
Title
Freedom from biochemical recurrence
Description
Rate of biochemical recurrence free survival, as determined by the Phoenix definition (PSA level of 2 ng/ml or more higher than the lowest post-SBRT value)
Time Frame
5 years after end of SBRT
Title
Patient-reported quality of life issues related to prostate cancer.
Description
Patient-reported quality of life changes during and after adaptive prostate SBRT treatment using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) questionnaire.
Time Frame
Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Title
Patient-reported erectile dysfunction symptoms
Description
Patient-reported erectile dysfunction symptoms before, during and after adaptive prostate SBRT treatment using the Sexual Health Inventory for Men (SHIM) questionnaire.
Time Frame
Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Title
Patient-reported urinary symptoms
Description
Patient-reported urinary symptoms before, during and after adaptive prostate SBRT treatment using the International Prostate Symptom Score (IPSS) questionnaire.
Time Frame
Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Title
Patient-reported overall quality of life
Description
Patient-reported overall quality of life before, during and after adaptive prostate SBRT treatment using the EQ-5D-5L questionnaire.
Time Frame
Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Title
Physician-reported toxicities
Description
Physician-reported CTCAE v 5.0 adverse events
Time Frame
During treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Title
Alpha-blocker medication use
Description
Change in use of alpha-blocker medications for urinary symptoms
Time Frame
Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT
Title
Metastasis-free survival
Description
Metastasis-free survival
Time Frame
5 years after end of SBRT
Title
Prostate-cancer specific mortality
Description
Prostate-cancer specific mortality
Time Frame
5 years after end of SBRT
Title
Overall survival
Description
Overall survival
Time Frame
5 years after end of SBRT
Title
Workflow metrics of adaptive SBRT for prostate cancer
Description
Includes the time on table and frequency of using the adapted vs. non-adapted treatment plan for each fraction.
Time Frame
2 weeks after start of SBRT
Title
Target and OAR dosimetry
Description
Improvement in target coverage and/or reduction in dose to critical organs at risk in the adapted plan compared to the non-adaptive planned dosimetry
Time Frame
2 weeks after start of SBRT
Title
Impact of rectal spacers
Description
Physician reported toxicity and patient reported outcomes with or without implanted resorbable rectal spacer
Time Frame
Enrollment through 5 year follow up
Other Pre-specified Outcome Measures:
Title
Decipher prognostic ability
Description
Correlation of the Decipher risk category (low/intermediate/high) with biochemical recurrence.
Time Frame
5 years after end of SBRT

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven. Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy. AUA/IPSS score is ≤ 15. ECOG performance status is ≤2 (or Karnofsky score is ≥60%). Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion). Patient has the ability to complete required patient questionnaires. Patient age ≥ 18 years (or greater than the local age of majority). Patient has the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patient has baseline grade ≥3 GI or GU toxicity Patient has had prior overlapping pelvic radiotherapy. Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation. Patient has node positive prostate cancer. Patient has extracapsular extension (capsular abutment is permitted). Patient has active inflammatory bowel disease or active collagen vascular disease. Patient cannot undergo prostate MRI. Patient cannot undergo prostate fiducial marker placement. Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Davidson, MASc
Phone
1-437-991-8294
Email
sean.davidson@varian.com
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Kohlymyer, MS
Phone
1-262-880-5099
Email
steve.kohlmyer@varian.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Leeman, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeremy Bredfeldt, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sinead Christensen
Phone
617-582-8264
Email
smchristensen@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Kris Zhai
Phone
(617) 582-8996
Email
bkzhai@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Leeman, MD
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candice Schwebel
Email
Candice.Schwebel@fccc.edu
First Name & Middle Initial & Last Name & Degree
Mark Hallman, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

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