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Localized Prostate AdenocarcinomaNCT06325046

Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer

A study testing Computed Tomography, Cone-Beam Computed Tomography and Image-Guided Adaptive Radiation Therapy in people with Localized Prostate Adenocarcinoma and Stage I Prostate Cancer AJCC v8, run by Mayo Clinic at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Computed Tomography, Cone-Beam Computed Tomography and Image-Guided Adaptive Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
5 sitesUnited States
Study dates
15 Aug 2024to 30 Apr 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

5 sites in 1 country

United States5 sites, 5 recruiting

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    John Yeakel, MD

    Recruiting

  • Mayo Clinic Health System-Eau Claire

    Eau Claire, Wisconsin, 54701

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Now Bahar Alam, MD

    Recruiting

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Abigail L. Stockham, MD

    Recruiting

  • Mayo Clinic Health System-Mankato

    Mankato, Minnesota, 56001

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Lydia W. Ng, MD

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Mark R. Waddle, M.D.

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate treatment-related, patient-reported early quality of life (QOL) changes between near "margin-less" ART in 2 fractions versus standard of care 3-5mm SABR in 5 fractions, using the Expanded Prostate Cancer Index Composite (EPIC)-26 bowel and urinary irritative/obstructive domains.

SECONDARY OBJECTIVES:

  1. To assess treatment-related, patient-reported late QOL changes after SABR using the EPIC-26 bowel and urinary irritative/obstructive domains.

II. To assess and compare early physician-reported grade ≥ 2 gastrointestinal (GI) and/or genitourinary (GU) toxicities of interest within 3 months after SABR using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

III. To assess and compare patient-reported financial toxicities, using the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity (FACIT-COST) assessment tool.

IV. To assess and compare late physician-reported grade ≥ 2 GI and/or GU toxicities of interest within 24 months after SABR using the CTCAE v5.0.

  1. To assess and compare change in International Index of Erectile Function (IIEF-15) and International Prostate Symptom Score (IPSS).

VI. To explore the association of fiducial-free treatment on dosimetry, patient reported outcomes (PROs), and toxicity.

VII. To explore the association of bladder filling on dosimetry, PROs, and toxicity.

VIII. To assess and compare the cumulative incidence of biochemical failure, local progression, distant metastasis, and metastasis-free survival within 60 months after SABR.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo near margin-less adaptive radiation therapy (ART) for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo cone beam computed tomography (CBCT) and may undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) on study.

ARM II: Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. 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.

Being tested
Computed Tomography, Cone-Beam Computed Tomography, Image-Guided Adaptive Radiation Therapy, Magnetic Resonance Imaging, Stereotactic Ablative Radiotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Cone-Beam Computed TomographyProcedure or surgery

    Also called Cone Beam Computed Tomography, Cone Beam CT

    Undergo CBCT

  • Image-Guided Adaptive Radiation TherapyRadiation

    Also called IGART

    Undergo near margin-less ART

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Stereotactic Ablative RadiotherapyProcedure or surgery

    Also called SABER, SABR, SABR/SBRT, Stereotactic Body Radiation Therapy (SBRT)

    Undergo standard SABR

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT06325046
Study groupRoleWhat they receive
Arm I (near margin-less ART)ExperimentalPatients undergo near margin-less ART for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CBCT and may undergo CT and/or MRI on study.
Receives: Procedure: Computed Tomography; Procedure: Cone-Beam Computed Tomography; Radiation: Image-Guided Adaptive Radiation Therapy; Procedure: Magnetic Resonance Imaging; Other: Survey Administration
Arm II (standard SABR)Active comparatorPatients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI on study.
Receives: Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Stereotactic Ablative Radiotherapy; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-related, patient-reported early quality of life (QOL) changes

    Will be assessed using the Expanded Prostate Cancer Index Composite (EPIC)-26. The EPIC-26 consists of 13 questions answered on a variety of scales, such as 1-5 where 1=very poor and 5=very good.

    Measured: Baseline; up to 3 months

Secondary outcomes (11)

  1. Treatment-related, patient-reported late QOL changes

    Will be assessed using the EPIC-26 questionnaire, as described above.

    Measured: Baseline; up to 24 months

  2. Incidence of grade ≥ 2 genitourinary an/or gastrointestinal adverse events

    Incidence of adverse events will be recorded at study visits. An adverse event is defined as any undesirable experience associated with the use of a medical product in a patient.

    Measured: Up to 24 months

  3. Change in International Index of Erectile Function (IIEF)

    The IIEF consists of 15 questions answered with various scales (e.g., a scale of 5-1 where 5=almost always or always and 1=almost never or never). Possible scores range from 5 to 25, and erectile dysfunction (ED) is classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).

    Measured: Baseline; up to 24 months

  4. Change in International Prostate Symptom Score (IPSS)

    The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life.Each question is answered on a scale of 0-5 where 0=not at all/none and 5=almost always/5 5times.

    Measured: Baseline; up to 24 months

  5. Change in financial adverse events - COST-FACIT

    Change in financial adverse events will be assessed using the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) assessment tool. The COST-FACIT consists of 12 questions, each answered on a scale of 0-4 where 0=not al all and 4=very much.

    Measured: Baseline; 12 months

  6. Fiducial-free treatment

    Will evaluate associations of fiducial-free treatment on dosimetry, patient reported outcomes (PROs), and toxicity. A fiducial is medical device or small object placed in or on the body to mark an area for radiation treatment or surgery. For example, tiny gold seeds may be put into the prostate to mark a tumor before radiation therapy.

    Measured: Up to 5 years

  7. Bladder filling

    Will evaluate associations of bladder filling on dosimetry, patient reported outcomes (PROs), and toxicity using Fisher's exact test and the nonparametric Wilcoxon sum rank test.

    Measured: Up to 5 years

  8. Biochemical recurrence

    Biochemical disease recurrence will be estimated using the Kaplan-Meier method and compared using the log-rank test for each timepoint. Biochemical failure is defined as a prostate-specific antigen (PSA) value that is ≥ PSA nadir + 2.0 ng/mL with the date of biochemical failure set at the date of the PSA value that meets this criterion.

    Measured: At 2 and 5 years

  9. Prostate specific antigen (PSA) kinetics

    Median PSA nadir as well as median time to nadir will be reported

    Measured: Up to 5 years

  10. Local recurrence

    Local recurrence is defined as Magnetic Resonance Imaging (MRI) or prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/Computed Tomography (CT) evidence of recurrence disease in conjunction with biochemical failures.

    Measured: Up to 5 years

  11. Overall survival

    Survival duration will be measured from the date of registration to the date of death from any cause.

    Measured: From the date of registration to the date of death from any cause, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2024
  2. Study start15 Aug 2024
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
164 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06325046
Sponsor's protocol ID
GMROR2351
Other IDs
23-003388
Status last verified
Oct 2026
First submitted
15 Mar 2024
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Computed Tomography, Cone-Beam Computed Tomography and Image-Guided Adaptive Radiation Therapy in people with Localized Prostate Adenocarcinoma and Stage I Prostate Cancer AJCC v8, run by Mayo Clinic at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-related, patient-reported early quality of life (QOL) changes (time frame: Baseline; up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06325046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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