ART of SABR: A Randomized Phase II Trial of Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer: Two Versus Five Fractions

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure, Radiation, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Gender assigned male at birth: age ≥ 18 years

• Histological confirmation of prostate adenocarcinoma

• National Comprehensive Cancer Network (NCCN) (Prostate Cancer version 4.2022) low- to intermediate-risk prostate adenocarcinoma

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• Ability to complete questionnaire(s) by themselves or with assistance

• Signed informed consent

• Willing to complete requirements for follow-up (during active monitoring phase)

Locations
United States
Minnesota
Mayo Clinic Health System in Albert Lea
RECRUITING
Albert Lea
Mayo Clinic Health System-Mankato
RECRUITING
Mankato
Mayo Clinic in Rochester
RECRUITING
Rochester
Wisconsin
Mayo Clinic Health System-Eau Claire
RECRUITING
Eau Claire
Mayo Clinic Health System-Franciscan Healthcare
RECRUITING
La Crosse
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2024-08-15
Estimated Completion Date: 2026-08
Participants
Target number of participants: 144
Treatments
Experimental: Arm I (near margin-less ART)
Patients undergo near margin-less ART for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CBCT and may undergo CT and/or MRI on study.
Active_comparator: Arm II (standard SABR)
Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI on study.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov