MRI-Guided Radiation Therapy for Prostate Cancer

Overseen By Adam Mueller, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Thomas Jefferson University

Must be taking: Hormone therapy

Disqualifiers: Metastasis, Life expectancy < 2 years, Previous prostate RT, TURP, Severe urinary symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat high-risk prostate cancer using MRI-guided radiation therapy. The goal is to determine if this approach can reduce treatment time and limit side effects by precisely targeting the cancer while sparing healthy tissue. The trial seeks participants diagnosed with high-risk prostate cancer who have not previously received radiation therapy to the pelvis. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that MRI-guided radiation therapy is safe for prostate cancer treatment?

Research shows that MRI-guided radiation therapy for prostate cancer is generally well-tolerated. Studies have demonstrated that MRI helps doctors target cancer more precisely. This method allows them to deliver higher radiation doses directly to the tumor while protecting healthy tissue.

One study found that patients did not experience severe side effects, known as grade 3 or higher adverse events, when treated with a similar method called highly hypofractionated IMRT, which involves fewer but larger doses of radiation. This finding suggests the treatment is safe for patients.

Another study highlighted that using MRI to guide radiation therapy can safely increase the radiation dose, potentially improving treatment outcomes without adding extra risk.

Overall, MRI-guided radiation therapy appears safe, with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for prostate cancer?

Researchers are excited about MRI-guided Intensity-Modulated Radiation Therapy (IMRT) for prostate cancer because it offers a more precise targeting method compared to traditional radiation therapies. Unlike standard treatments that might affect surrounding tissues, this technique uses real-time MRI imaging to focus radiation more accurately on the tumor, potentially reducing side effects. Additionally, MRI-guided IMRT is often paired with Androgen Deprivation Therapy (ADT), enhancing its effectiveness by targeting cancer cells more effectively. This precision and combination approach could lead to better outcomes and an improved quality of life for patients.

What evidence suggests that MRI-guided radiation therapy is effective for prostate cancer?

Research has shown that MRI-guided intensity-modulated radiation therapy (MRI-guided IMRT) holds promise for treating prostate cancer. This method enables doctors to target cancer cells with higher radiation doses while safeguarding healthy tissue. Consequently, patients may experience improved outcomes and fewer side effects compared to traditional treatments. One study found that using MRI-guided radiation in a shorter treatment plan resulted in fewer severe side effects, with no serious negative reactions. Overall, MRI-guided IMRT offers a safer and potentially more effective option for patients with high-risk prostate cancer. ^{1 2 4 5 6}

Who Is on the Research Team?

Jessie DiNome, MD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for English-speaking men with high-risk prostate cancer, defined by a Gleason score of 8-10, stage T3a or higher, or PSA > 20 ng/mL. They must have no prior pelvic radiation, no positive lymph nodes or distant metastasis confirmed by scans, be able to undergo long-term hormone therapy and have a Karnofsky performance score over 70.

Inclusion Criteria

Participants must be histologically proven, adenocarcinoma prostate

High risk prostate cancer as defined by National Comprehensive Cancer Network (NCCN): Gleason score of 8-10, clinical stage T3a or higher, or prostate specific antigen (PSA) > 20 ng/mL

English speaking/reading

Exclusion Criteria

Your doctor thinks you are likely to live less than 2 years.

Any contraindication to radiotherapy such as inflammatory bowel disease

Previous radiation therapy (RT) to prostate or prostatectomy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo MRI-guided intensity-modulated radiation therapy (IMRT) and receive standard of care antiandrogen therapy (ADT) throughout the trial

6-8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 3 months for 2 years and then every 6 months for a total of 4 years

4 years

Every 3 months for 2 years, then every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• MRI-guided Intensity-Modulated Radiation Therapy

Trial Overview The study tests MRI-guided hypofractionated radiation therapy aimed at reducing treatment time and side effects in patients with high-risk prostate cancer. It involves delivering higher doses of radiation over fewer sessions to minimize damage to healthy tissue.

How Is the Trial Designed?

Group I: Treatment (MRI-guided IMRT, ADT) Experimental Treatment 8 Interventions

Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9399820/

Long-term outcomes of prostate intensity-modulated ... This retrospective study demonstrates the long-term outcomes of treating prostate cancer using intensity modulated (IMRT) with incorporation of MRI-directed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10526919/

MRI-Guided Radiation Therapy for Prostate Cancer In this review, we discuss the advantages and limitations of MRIgRT for prostate cancer, as well as clinical trials testing the efficacy and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405630824000193

MRI-guided radiotherapy in twenty fractions for localised ... This study examines the potential clinical benefits of MRIgRT for men with localised prostate cancer, in the setting of moderately hypofractionated radiotherapy ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1879850023001753

Long-Term Outcomes of a Prospective Study on Highly ... No grade ≥3 adverse events were observed, suggesting that highly hypofractionated IMRT is a safe treatment. Conventional fractionated radiation therapy at 1.8 ...

5. tau.amegroups.org tau.amegroups.org/article/view/17922/html

Intensity-modulated radiotherapy for prostate cancer Multiple clinical trials have demonstrated improved cancer outcomes with dose escalation, but toxicities using 3D-CRT and escalated doses have been problematic.

6. cancer.org cancer.org/cancer/types/prostate-cancer/treating/radiation-therapy.html

Side Effects of Radiation Therapy for Prostate Cancer This type of radiation can be used to try to cure earlier-stage cancers, to treat cancers that have grown outside the prostate, or to help relieve symptoms ...