NCT06325046 Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer
| NCT ID | NCT06325046 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Localized Prostate Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2024-08-15 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 164 participants in total. It began in 2024-08-15 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Mark R. Waddle, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT06325046 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Localized Prostate Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06325046 currently recruiting?
Yes, NCT06325046 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT06325046 trial being conducted?
This trial is being conducted at Albert Lea, United States, Mankato, United States, Rochester, United States, Eau Claire, United States and 1 additional location.
Who is sponsoring the NCT06325046 clinical trial?
NCT06325046 is sponsored by Mayo Clinic. The principal investigator is Mark R. Waddle, MD at Mayo Clinic in Rochester. The trial plans to enroll 164 participants.