RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-15
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06325046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Gender assigned male at birth: age ≥ 18 years
  2. * Histological confirmation of prostate adenocarcinoma
  3. * National Comprehensive Cancer Network (NCCN) (Prostate Cancer version 4.2022) low- to intermediate-risk prostate adenocarcinoma
  4. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  5. * Ability to complete questionnaire(s) by themselves or with assistance
  6. * Signed informed consent
  7. * Willing to complete requirements for follow-up (during active monitoring phase)
  1. * NCCN (Prostate Cancer version 4.2022) very low-, high-, or very high-risk prostate adenocarcinoma
  2. * Prior definitive treatment of prostate cancer including radiotherapy, prostatectomy, cryotherapy, or high intensity focused ultrasound (HIFU)
  3. * Prior bladder outlet obstruction procedures including transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), transurethral vaporesection of the prostate (TUVRP), etc.
  4. * Metastatic disease by conventional or molecular imaging
  5. * Contraindications to radiation therapy (RT) including uncontrolled inflammatory bowel disease, ATM mutation, and Xeroderma pigmentosum mutation
  6. * Concurrent antineoplastic agents (chemotherapy)
  7. * Previous or concurrent malignancy other than non-melanoma skin cancer, indolent lymphoma, or chronic myelogenous leukemia, unless continuously disease-free ≥ 5 years
  8. * Medical or psychiatric conditions that preclude informed decision-making or adherence with the protocol-defined treatment or follow-up
  9. * Prostate gland volume \> 80 cc based on magnetic resonance imaging (MRI), and/or International Prostate Symptom Score (IPSS) composite score \> 17
  10. * Body weight \> 200 kilogram
  11. * Known allergy or sensitivity to polyethylene glycol (PEG) or iodine

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Mark R. Waddle, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
United States
Mayo Clinic Health System-Mankato
Mankato, Minnesota, 56001
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Mayo Clinic Health System-Eau Claire
Eau Claire, Wisconsin, 54701
United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Mark R. Waddle, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-15
Study Completion Date2026-08

Study Record Updates

Study Start Date2024-08-15
Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

  • Localized Prostate Adenocarcinoma
  • Stage I Prostate Cancer AJCC V8
  • Stage II Prostate Cancer AJCC V8
  • Stage III Prostate Cancer AJCC V8