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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 60 months
  • Procedures mentioned: MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients also undergo cone beam computed tomography (CBCT) and may undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) on study."
  • "Patients also undergo CT and/or MRI on study."
  • "After completion of study treatment, patients are followed up at months 1, 3, and 6, and then every 6 months for up to 60 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two visits for radiation that is adjusted during treatment with five visits for standard, precisely aimed radiation. It looks at changes in quality of life in adults with low- to medium-risk prostate cancer that has not spread.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You were assigned male at birth and are age 18 or older.
  • A tissue test confirmed prostate adenocarcinoma, a type of prostate cancer.
  • Your prostate cancer is low or medium risk under the study’s guidelines.
  • You can care for yourself and are out of bed or a chair for more than half of your waking hours.
  • You can fill out surveys on your own or with help.
  • You have signed a form agreeing to join after learning about the study.
  • You are willing to complete the required follow-up visits and checks.

Who can't join

  • Your prostate cancer is very low, high, or very high risk, or scans show that cancer has spread.
  • You already had treatment to remove or destroy prostate cancer, such as radiation, surgery, freezing, or focused ultrasound.
  • You had a procedure to remove prostate tissue to help urine flow.
  • You cannot safely have radiation because of conditions such as uncontrolled bowel inflammation, an ATM gene change, or a gene change linked to xeroderma pigmentosum.
  • You are receiving chemotherapy or other cancer drugs, or have had another cancer without being cancer-free for at least 5 years. Exceptions include non-melanoma skin cancer, slow-growing lymphoma, and chronic myelogenous leukemia.
  • A physical or mental health condition prevents you from making an informed choice or following the study’s treatment and follow-up plan.
  • Your prostate is larger than 80 cubic centimeters on an MRI scan, your urine symptom score is above 17, or you weigh more than 200 kilograms.
  • You have a known allergy or sensitivity to polyethylene glycol (PEG) or iodine.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (5)

MN

WI