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

Official record

Identifier

NCT06325046

Recruiting locations

country

United States

Interventions studied

Computed TomographyCone-Beam Computed TomographyImage-Guided Adaptive Radiation TherapyMagnetic Resonance ImagingStereotactic Ablative RadiotherapySurvey Administration

Lead sponsor

Mayo Clinic

Target enrolment

164 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Recruiting

First posted

Mar 22, 2024

Last updated on the registry

Jul 30, 2026

Age

18 Years

Sex

MALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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
* Known allergy or sensitivity to polyethylene glycol (PEG) or iodine

Indexed under

Prostate Cancer