Adaptive radiation therapy for localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Image-guided adaptive stereotactic body radiation therapy for localized prostate cancer

  This trial tests whether daily, real-time adaptive image-guided SBRT causes fewer urinary and other side effects than standard non-adaptive SBRT for men with localized prostate cancer.

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• MRI or CT planning to guide high-dose-rate prostate brachytherapy

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• Exercise after pelvic radiation to see if it lowers colorectal cancer risk

  This study tests whether regular walking therapy after pelvic radiation for prostate cancer can influence markers of colorectal cancer in colon tissue and blood.

  Recruiting at 2 sites City of Hope Medical Center · Duarte, California and 1 other locations · NCT07790718

• Wrapping nerves with a multi-layer perinatal tissue graft during prostate removal

  This trial will test whether wrapping the nerves with a multi-layer perinatal tissue allograft during nerve-sparing robotic prostate removal helps men with localized prostate cancer keep erectile and urinary function.

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• Testosterone therapy for men with low testosterone and localized prostate cancer on active surveillance

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• Using advanced imaging to predict lymph node spread in high-risk prostate cancer

  This study is testing a new imaging method to see if it can help doctors predict whether high-risk prostate cancer has spread to lymph nodes before surgery.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT06389786

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.