What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as external beam radiation therapy (EBRT) and radical prostatectomy, have well-documented side effects. EBRT can cause acute urinary symptoms like frequency, dysuria, and urgency, which typically resolve within weeks after treatment. Bowel symptoms, including radiation proctitis, can also occur but usually subside within a few weeks to months. Sexual dysfunction is another common side effect, with erectile dysfunction increasing over time. Adaptive radiotherapy with urethral sparing aims to minimize these urinary side effects by tailoring the radiation dose to reduce exposure to the urethra, potentially leading to fewer acute urinary symptoms compared to traditional methods.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer include various forms of radiotherapy and androgen deprivation therapy (ADT). Radiotherapy options include external beam radiation therapy (EBRT) and brachytherapy, both of which have been used to treat localized prostate cancer. Advanced techniques like stereotactic body radiotherapy (SBRT) and intensity-modulated radiation therapy (IMRT) have been developed to deliver higher doses of radiation with precision, minimizing damage to surrounding tissues. Additionally, drugs like abiraterone and enzalutamide have been approved for castration-resistant prostate cancer (CRPC), often used in combination with ADT. These treatments aim to improve outcomes while managing side effects, similar to the goals of adaptive radiotherapy with urethral sparing.

What other types of research exist?

Promising alternatives to Adaptive Radiotherapy with Urethral Sparing for prostate cancer patients include: 1) Stereotactic Body Radiotherapy (SBRT), which delivers high doses of radiation in fewer sessions with precision, potentially reducing side effects. 2) Proton Beam Therapy, which uses protons instead of X-rays to target tumors more precisely, sparing surrounding healthy tissue. 3) Immunotherapy, particularly checkpoint inhibitors, which enhance the body's immune response against cancer cells. 4) Combination therapies, such as radiotherapy combined with androgen deprivation therapy (ADT) or novel systemic agents, which may improve treatment outcomes. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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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 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

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.

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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.