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Can MRI-Guided radiation zero in on prostate tumors with fewer side effects?

NCT ID NCT07769372

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial is testing a new way to deliver radiation therapy for prostate cancer. Instead of standard radiation, it uses MRI to precisely target the tumor, potentially sparing healthy tissue and reducing side effects. The study will include about 20 adults with early-stage prostate cancer and will focus on safety and how well the treatment works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MR-guided stereotactic body radiation therapy (SBRT)
What this could lead to
If successful, this approach could offer a more precise, less damaging radiation treatment for prostate cancer, potentially reducing side effects and improving quality of life.
What could go wrong
This is a small pilot study, so results may not be conclusive. There is a risk of side effects from radiation, and the treatment may not be more effective than standard approaches.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Documented informed consent of the participant and/or Legally Authorized Representative * Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * National Comprehensive Cancer Network (NCCN) low-risk or intermediate-risk prostate cancer, defined as: * Low-risk: Prostate-specific antigen (PSA) \< 10 ng/mL AND grade group 1 (Gleason score 3+3) AND clinical stage T1-T2a * Intermediate-risk (one or more of the following intermediate risk factors \[IRFs\]): PSA 10-20 ng/mL, grade group 2 or 3 (Gleason 3+4 or 4+3), or clinical stage T2b-T2c * Favorable intermediate-risk (all of the following): 1 IRF, grade group 1 or 2, \< 50% cores positive * Unfavorable intermediate-risk (one or more of the following): 2 or 3 IRFs, grade group 3, ≥ 50% cores positive * Biopsies from a single region of interest (ROI) are counted as a single sample * Diagnostic multiparametric MRI (mpMRI) of the prostate (within 6 months prior to enrollment) with MRI-visible dominant lesion defined as Prostate Imaging-Reporting and Data System (PI-RADS) ≥ 3 * Prostate biopsy, including targeted and systematic biopsy. All PI-RADS ≥ 3 lesions must be sampled by MRI-targeted biopsy. Biopsy results must confirm concordance between the MRI-visible lesion and histologically confirmed prostate adenocarcinoma. Patients with any positive biopsy core (any grade group) from a region not attributable to the MRI-defined PI-RADS ≥ 3 lesion(s) are excluded * Unilateral disease, defined as: the MRI-visible dominant lesion(s) and all biopsy-confirmed prostate cancer confined to one prostatic lobe. Multiple lesions are permitted provided they can be encompassed within a single focal treatment planning volume * Agreement by males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of protocol therapy * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * Chemotherapy, biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy * Current or planned androgen deprivation therapy (ADT), including leutenizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, antiandrogens, or prior bilateral orchiectomy. Prior 5-alpha reductase inhibitor use is permitted if discontinued ≥ 90 days prior to baseline PSA assessment or if the corrected PSA value (measured PSA × 2) meets protocol risk group eligibility criteria (≤ 20 ng/mL) * Prior focal therapy for prostate cancer, including but not limited to high intensity focused ultrasound (HIFU), cryotherapy, irreversible electroporation (IRE), laser ablation, or photodynamic therapy * Prior pelvic radiation therapy * Prior prostate procedures for BPH (including but not limited to transurethral resection of the prostate \[TURP\], UroLift, Aquablation, Rezūm, prostate artery embolization) that, in the opinion of the treating radiation oncologist, have significantly altered prostatic anatomy such that focal SBRT treatment planning would be compromised or leads to increased risk of treatment-related toxicity * For patients with severe baseline lower urinary tract symptoms (International Prognostic Scoring System \[IPSS\] ≥ 20), the treating radiation oncologist should confirm that the patient's baseline urinary function and location/volume of target does not, in their clinical judgment, represent an unacceptable risk for treatment-related urinary morbidity * Clinically significant uncontrolled illness. Patients that are known to be HIV-infected that are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Patient has baseline grade ≥ 3 gastrointestinal (GI) or genitourinary (GU) toxicity * History of prior rectal surgery (e.g., low anterior resection, abdominoperineal resection) or other pelvic surgery that, in the opinion of the treating radiation oncologist, would significantly alter normal pelvic anatomy and compromise safe treatment delivery * Active inflammatory bowel disease (ulcerative colitis or Crohn's disease) involving the rectum or sigmoid colon * Contraindication to magnetic resonance imaging, including but not limited to: * Implanted metallic devices not certified as MRI-conditional (e.g., non-MRI-conditional cardiac pacemakers, defibrillators, neurostimulators, cochlear implants, metallic foreign bodies) * Severe claustrophobia not manageable with anxiolytic medication and/or supportive measures * Inability to tolerate supine positioning for the duration of MR-guided treatment delivery (approximately 30-45 minutes per fraction) * Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope at Irvine Lennar

    Irvine, California, 92618, United States

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Other studies related to the condition(s) this trial covers.