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NCT Number: NCT05804318

Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum der Landeshauptstadt Stuttgart gKAöR, Stuttgart, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven.
  • Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy.
  • AUA/IPSS score is ≤ 15.
  • ECOG performance status is ≤2 (or Karnofsky score is ≥60%).
  • Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion).
  • Patient has the ability to complete required patient questionnaires.
  • Patient age ≥ 18 years (or greater than the local age of majority).
  • Patient has the ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

  • Patient has baseline grade ≥3 GI or GU toxicity
  • Patient has had prior overlapping pelvic radiotherapy.
  • Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation.
  • Patient has node positive prostate cancer.
  • Patient has extracapsular extension (capsular abutment is permitted).
  • Patient has active inflammatory bowel disease or active collagen vascular disease.
  • Patient cannot undergo prostate MRI.
  • Patient cannot undergo prostate fiducial marker placement.
  • Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).

Treatment and study plan

Daily adaptive SBRT with urethral sparing

Device

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 outcomes

  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 outcomes

  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 outcomes

  1. Decipher prognostic ability

    Time frame: 5 years after end of SBRT

    Correlation of the Decipher risk category (low/intermediate/high) with biochemical recurrence.

Study contacts

Contact information is provided by the study sponsor or research team.

Claire McCann, PhD

CONTACT

[email protected]

Sean Davidson, MASc

CONTACT

[email protected]

1-437-991-8294

Sponsors and collaborators

Lead sponsor

Varian, a Siemens Healthineers Company

Industry

Registry information

Official study title

Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity

Acronym: ARTIA-Prostate

Important dates

Study start
2023
Primary completion
2026
Study completion
2031
First posted
Apr 7, 2023
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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