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Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests radiation treatment that is adjusted each day to help protect the urethra, the tube that carries urine out of the body. It is for adults with low- or intermediate-risk prostate cancer that has not spread outside the prostate. The study uses patient surveys to see if this approach causes fewer short-term urinary side effects than reported with an earlier radiation approach.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have low- or intermediate-risk prostate cancer confirmed by a biopsy (a tissue sample).
  • Have a prostate size of 80 cubic centimeters or less on an MRI scan before radiation.
  • Have a score of 15 or less on the AUA/IPSS survey of urinary symptoms.
  • Can care for yourself at least partly, with an ECOG activity score of 2 or less or a Karnofsky score of 60% or more.
  • Have no highly suspicious area on prostate MRI (PI-RADS 4 or 5) touching the urine tube, as judged by the doctor.
  • Can complete the required patient surveys.
  • Are at least 18 years old, or above the local legal age for adults.
  • Can understand the study and are willing to sign a consent form.

Who can't join

  • Already have severe bowel or urinary problems, rated grade 3 or higher.
  • Have had radiation to the pelvis that overlaps the planned treatment area.
  • Have had prostate tissue removed through the urine tube, or prostate treatment using high-intensity focused ultrasound (HIFU) or freezing.
  • Have prostate cancer that has spread to lymph nodes.
  • Have cancer growing beyond the prostate's outer covering. Cancer touching this covering is allowed.
  • Have active inflammatory bowel disease or active collagen vascular disease (disease affecting the body's support tissues).
  • Cannot have a prostate MRI or have small markers placed in the prostate to guide radiation.
  • Are currently getting cell-killing chemotherapy. Hormone treatment that lowers male hormones is allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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).

Study sites (5)

CA

MA

MO

PA