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Radiation Therapy
Adaptive Radiation Therapy for Prostate Cancer (ARTIA-Prostate Trial)
N/A
Recruiting
Led By Jonathan Leeman, MD
Research Sponsored by Varian, a Siemens Healthineers Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment through 5 year follow up
Awards & highlights
ARTIA-Prostate Trial Summary
This trial looks at using a new form of radiation therapy to treat prostate cancer and reduce urinary side effects.
Who is the study for?
This trial is for men at least 18 years old with low or intermediate risk prostate cancer confirmed by biopsy. Their prostate must be relatively small (≤80cc), they should have mild to moderate urinary symptoms (AUA/IPSS score ≤ 15), and be in fair health (ECOG ≤2 or Karnofsky ≥60%). They must not have aggressive cancer lesions touching the urethra, can fill out questionnaires, and agree to sign consent.Check my eligibility
What is being tested?
The study tests a new way of giving radiation therapy called daily adaptive SBRT that tries to protect the urethra from damage. It's hoped this method will reduce immediate urinary side effects compared to traditional methods. Patients' experiences are tracked using a specific questionnaire.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include typical radiation therapy issues like irritation of the bladder and bowel, fatigue, erectile dysfunction, and skin changes in treated areas.
ARTIA-Prostate Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment through 5 year follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment through 5 year follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient-reported acute urinary toxicity
Secondary outcome measures
Alpha-blocker medication use
Freedom from biochemical recurrence
Impact of rectal spacers
+10 moreOther outcome measures
Decipher prognostic ability
ARTIA-Prostate Trial Design
1Treatment groups
Experimental Treatment
Group I: Adaptive SBRT with Urethral SparingExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Varian, a Siemens Healthineers CompanyLead Sponsor
30 Previous Clinical Trials
7,141 Total Patients Enrolled
3 Trials studying Prostate Cancer
137 Patients Enrolled for Prostate Cancer
Jonathan Leeman, MDPrincipal InvestigatorBrigham and Women's Hospital
3 Previous Clinical Trials
636 Total Patients Enrolled
2 Trials studying Prostate Cancer
536 Patients Enrolled for Prostate Cancer
Jeremy Bredfeldt, PhDPrincipal InvestigatorBrigham and Women's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.I am currently not on cytotoxic chemotherapy, but I may be on hormone therapy.I have had pelvic radiotherapy before.My prostate cancer has spread to my lymph nodes.My prostate cancer is confirmed by biopsy and is considered low or intermediate risk.My prostate is smaller than or equal to 80cc, confirmed by MRI.I have an active inflammatory bowel or connective tissue disease.I have had surgery or treatments like HIFU or cryoablation for prostate issues.My cancer has spread outside the capsule of the organ.I am 18 years old or older.I have severe gastrointestinal or urinary problems.I cannot have markers placed in my prostate for treatment.I can understand and am willing to sign the consent form.My MRI shows no high-risk prostate cancer touching the urethra.
Research Study Groups:
This trial has the following groups:- Group 1: Adaptive SBRT with Urethral Sparing
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications to this medical experiment still being accepted?
"Evidently, this study is not actively recruiting based on information stored in the clinicaltrials.gov database; it was posted April 1st 2023 and last updated March 26th 2023. Despite this trial's pause of recruitment, there are still 1312 other medical studies searching for participants presently."
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