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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
No Placebo-Only Group

Summary

This trial is testing a new type of radiation treatment that adjusts to changes in the body and protects the urethra. It aims to help men with low to intermediate risk prostate cancer experience fewer urinary problems compared to traditional treatments.

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment through 5 year follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment through 5 year follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient-reported acute urinary toxicity
Secondary study objectives
Alpha-blocker medication use
Freedom from biochemical recurrence
Impact of rectal spacers
+10 more
Other study objectives
Decipher prognostic ability

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prostate cancer include androgen deprivation therapy (ADT), radiation therapy, and surgical interventions. ADT works by lowering testosterone levels, which prostate cancer cells rely on for growth. Radiation therapy, including advanced techniques like intensity-modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT), targets cancer cells with high doses of radiation while sparing surrounding healthy tissue. The trial on adaptive radiotherapy with urethral sparing aims to further refine this approach by tailoring the radiation dose to minimize exposure to the urethra, potentially reducing urinary side effects. These mechanisms are crucial as they aim to effectively treat cancer while minimizing adverse effects, thereby improving the quality of life for patients.

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Who is running the clinical trial?

Varian, a Siemens Healthineers CompanyLead Sponsor
33 Previous Clinical Trials
7,045 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

Media Library

SBRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05804318 — N/A
Prostate Cancer Research Study Groups: Adaptive SBRT with Urethral Sparing
~24 spots leftby Mar 2025
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