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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05804318
Recruitment Status : Recruiting
First Posted : April 7, 2023
Last Update Posted : September 6, 2023
Sponsor:
Information provided by (Responsible Party):
Varian, a Siemens Healthineers Company

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Daily adaptive SBRT with urethral sparing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 13, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Adaptive SBRT with Urethral Sparing
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.
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.




Primary Outcome Measures :
  1. Patient-reported acute urinary toxicity [ Time Frame: 90 days after end of SBRT ]
    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 :
  1. Freedom from biochemical recurrence [ Time Frame: 5 years after end of SBRT ]
    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)

  2. Patient-reported quality of life issues related to prostate cancer. [ 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 ]
    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.

  3. Patient-reported erectile dysfunction 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 ]
    Patient-reported erectile dysfunction symptoms before, during and after adaptive prostate SBRT treatment using the Sexual Health Inventory for Men (SHIM) questionnaire.

  4. Patient-reported 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 ]
    Patient-reported urinary symptoms before, during and after adaptive prostate SBRT treatment using the International Prostate Symptom Score (IPSS) questionnaire.

  5. Patient-reported overall quality of life [ 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 ]
    Patient-reported overall quality of life before, during and after adaptive prostate SBRT treatment using the EQ-5D-5L questionnaire.

  6. Physician-reported toxicities [ 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 ]
    Physician-reported CTCAE v 5.0 adverse events

  7. Alpha-blocker medication use [ 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 ]
    Change in use of alpha-blocker medications for urinary symptoms

  8. Metastasis-free survival [ Time Frame: 5 years after end of SBRT ]
    Metastasis-free survival

  9. Prostate-cancer specific mortality [ Time Frame: 5 years after end of SBRT ]
    Prostate-cancer specific mortality

  10. Overall survival [ Time Frame: 5 years after end of SBRT ]
    Overall survival

  11. Workflow metrics of adaptive SBRT for prostate cancer [ Time Frame: 2 weeks after start of SBRT ]
    Includes the time on table and frequency of using the adapted vs. non-adapted treatment plan for each fraction.

  12. Target and OAR dosimetry [ Time Frame: 2 weeks after start of SBRT ]
    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

  13. Impact of rectal spacers [ Time Frame: Enrollment through 5 year follow up ]
    Physician reported toxicity and patient reported outcomes with or without implanted resorbable rectal spacer


Other Outcome Measures:
  1. Decipher prognostic ability [ Time Frame: 5 years after end of SBRT ]
    Correlation of the Decipher risk category (low/intermediate/high) with biochemical recurrence.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05804318


Contacts
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Contact: Sean Davidson, MASc 1-437-991-8294 sean.davidson@varian.com
Contact: Steve Kohlymyer, MS 1-262-880-5099 steve.kohlmyer@varian.com

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sinead Christensen    617-582-8264    smchristensen@bwh.harvard.edu   
Contact: Kris Zhai    (617) 582-8996    bkzhai@bwh.harvard.edu   
Principal Investigator: Jonathan Leeman, MD         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Candice Schwebel       Candice.Schwebel@fccc.edu   
Principal Investigator: Mark Hallman, MD         
Sponsors and Collaborators
Varian, a Siemens Healthineers Company
Investigators
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Principal Investigator: Jonathan Leeman, MD Brigham and Women's Hospital
Principal Investigator: Jeremy Bredfeldt, PhD Brigham and Women's Hospital
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Responsible Party: Varian, a Siemens Healthineers Company
ClinicalTrials.gov Identifier: NCT05804318    
Other Study ID Numbers: VAR-2021-10
First Posted: April 7, 2023    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases