Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer

Part of paid clinical trials in Albert Lea, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06325046
Status
Recruiting
Apply to this trial

Conditions

  • Localized Prostate Adenocarcinoma
  • Stage I Prostate Cancer AJCC v8
  • Stage II Prostate Cancer AJCC v8
  • Stage III Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Undergo CT
  • Cone-Beam Computed Tomography — PROCEDURE
    Undergo CBCT
  • Image-Guided Adaptive Radiation Therapy — RADIATION
    Undergo near margin-less ART
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Stereotactic Ablative Radiotherapy — PROCEDURE
    Undergo standard SABR
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Aug 15, 2024
Status verified
Mar 2026
Primary completion
Aug 30, 2026
Completion
Aug 30, 2031

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Treatment-related, patient-reported early quality of life (QOL) changes [ Time Frame: Baseline; up to 3 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic Health System in Albert LeaAlbert LeaMinnesota56007
Clinical Trials Referral Office
[email protected]
855-776-0015
John Yeakel, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System-MankatoMankatoMinnesota56001
Clinical Trials Referral Office
[email protected]
855-776-0015
Lydia W. Ng, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Mark R. Waddle, M.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System-Eau ClaireEau ClaireWisconsin54701
Clinical Trials Referral Office
[email protected]
855-776-0015
Now Bahar Alam, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System-Franciscan HealthcareLa CrosseWisconsin54601
Clinical Trials Referral Office
[email protected]
855-776-0015
Abigail L. Stockham, MD (PRINCIPAL_INVESTIGATOR)

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