Adaptive radiation therapy for 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
NA · Mayo Clinic · NCT06325046
This study is testing a new type of radiation therapy for localized prostate cancer to see if it can improve patients' quality of life compared to standard treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Mayo Clinic (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Albert Lea, Minnesota and 4 other locations) |
| Trial ID | NCT06325046 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of near margin-less adaptive radiation therapy (ART) on quality of life in patients with localized prostate cancer, comparing it to standard stereotactic ablative body radiotherapy (SABR). The study aims to assess early and late patient-reported quality of life changes, gastrointestinal and genitourinary toxicities, and financial impacts associated with the treatments. ART utilizes real-time data to adjust radiation delivery, potentially reducing exposure to healthy tissues and shortening treatment duration. Participants will undergo assessments using validated questionnaires and toxicity grading scales to measure outcomes.
Who should consider this trial
Good fit: Ideal candidates include adult males aged 18 and older with histologically confirmed low- to intermediate-risk localized prostate adenocarcinoma.
Not a fit: Patients with very low-, high-, or very high-risk prostate adenocarcinoma or those who have received prior definitive treatment for prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved quality of life and reduced side effects for patients undergoing treatment for localized prostate cancer.
How similar studies have performed: Other studies have shown promise with adaptive radiation therapy approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Albert Lea, Minnesota and 4 other locations
- Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States (RECRUITING)
- Mayo Clinic Health System-Mankato — Mankato, Minnesota, United States (RECRUITING)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
- Mayo Clinic Health System-Eau Claire — Eau Claire, Wisconsin, United States (RECRUITING)
- Mayo Clinic Health System-Franciscan Healthcare — La Crosse, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Mark R. Waddle, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Localized Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8