Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer
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
Mayo Clinic
144 participants
Aug 15, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria11
- 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
Interventions
Undergo near margin-less ART
Undergo MRI
Undergo standard SABR
Ancillary studies
Undergo CT
Undergo CBCT
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06325046