Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804318
• Other study ID #: VAR-2021-10
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2023
• Est. completion date: March 2030

Study information

• Verified date: April 2024
• Source: Varian, a Siemens Healthineers Company
• Contact: Sean Davidson, MASc
• Phone: 1-437-991-8294
• Email: sean.davidson[@]varian.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: March 2030
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven.

2. Prostate volume is =80cc as assessed by MRI prior to radiotherapy.

3. AUA/IPSS score is = 15.

4. ECOG performance status is =2 (or Karnofsky score is =60%).

5. Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion).

6. Patient has the ability to complete required patient questionnaires.

7. Patient age = 18 years (or greater than the local age of majority).

8. Patient has the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patient has baseline grade =3 GI or GU toxicity

2. Patient has had prior overlapping pelvic radiotherapy.

3. Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation.

4. Patient has node positive prostate cancer.

5. Patient has extracapsular extension (capsular abutment is permitted).

6. Patient has active inflammatory bowel disease or active collagen vascular disease.

7. Patient cannot undergo prostate MRI.

8. Patient cannot undergo prostate fiducial marker placement.

9. Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Daily adaptive SBRT with urethral sparing
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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Varian, a Siemens Healthineers Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Decipher prognostic ability	Correlation of the Decipher risk category (low/intermediate/high) with biochemical recurrence.	5 years after end of SBRT
Primary	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.	90 days after end of SBRT
Secondary	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)	5 years after end of SBRT
Secondary	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.	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
Secondary	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.	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
Secondary	Patient-reported urinary symptoms	Patient-reported urinary symptoms before, during and after adaptive prostate SBRT treatment using the International Prostate Symptom Score (IPSS) questionnaire.	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
Secondary	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.	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
Secondary	Physician-reported toxicities	Physician-reported CTCAE v 5.0 adverse events	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
Secondary	Alpha-blocker medication use	Change in use of alpha-blocker medications for urinary symptoms	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
Secondary	Metastasis-free survival	Metastasis-free survival	5 years after end of SBRT
Secondary	Prostate-cancer specific mortality	Prostate-cancer specific mortality	5 years after end of SBRT
Secondary	Overall survival	Overall survival	5 years after end of SBRT
Secondary	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.	2 weeks after start of SBRT
Secondary	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	2 weeks after start of SBRT
Secondary	Impact of rectal spacers	Physician reported toxicity and patient reported outcomes with or without implanted resorbable rectal spacer	Enrollment through 5 year follow up