Evaluating Changes in Quality of Life After Near Margin-less Adaptive Radiation Therapy Compared to Standard Stereotactic Ablative Body Radiotherapy in Localized Prostate Cancer

Overview

About this study

The purpose of this study is to assess treatment-related, patient-reported early QOL changes after stereotactic ablative body radiotherapy (SABR) using the EPIC-26 bowel and bladder domains.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • NCCN (Prostate Cancer version 4.2022) very low-, high-, or very high-risk prostate adenocarcinoma
  • Prior definitive treatment of prostate cancer including radiotherapy, prostatectomy, cryotherapy, or high intensity focused ultrasound (HIFU)
  • 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.
  • Metastatic disease by conventional or molecular imaging
  • Contraindications to radiation therapy (RT) including uncontrolled inflammatory bowel disease, ATM mutation, and Xeroderma pigmentosum mutation
  • Concurrent antineoplastic agents (chemotherapy)
  • Previous or concurrent malignancy other than non-melanoma skin cancer, indolent lymphoma, or chronic myelogenous leukemia, unless continuously disease-free ≥ 5 years
  • Medical or psychiatric conditions that preclude informed decision-making or adherence with the protocol-defined treatment or follow-up
  • Prostate gland volume > 80 cc based on magnetic resonance imaging (MRI), and/or International Prostate Symptom Score (IPSS) composite score > 17
  • Body weight > 200 kilogram

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 06/27/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mark Waddle, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available