High-Dose Radiation Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Victoria Brennan, MBBCH BAO

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Androgen deprivation therapy

Disqualifiers: Gleason score >7, PSA >20, Metastatic disease, MRI ineligibility, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

One of the usual approaches to treating intermediate-risk prostate cancer is a type of radiation therapy called SBRT (stereotactic body radiation therapy). SBRT delivers higher than standard doses of radiation over a lower number of treatment sessions. However, there is a 20% chance that intermediate-risk prostate cancer will come back after this treatment. The purpose of this study is to find out whether giving an even higher dose (a "boost" dose) of radiation directly to the main tumor and the standard dose of radiation to the rest of the prostate may cure the cancer or prevent it from coming back for a longer period of time while causing few side effects.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment MRI-guided High-dose Radiation Therapy for prostate cancer?

Research shows that MRI-guided radiation therapy for prostate cancer can improve treatment accuracy by better visualizing the prostate and adjusting for movement, which helps protect surrounding healthy tissues. This approach has been shown to reduce certain side effects compared to traditional methods, making it a promising option for treating prostate cancer. ^{1 2 3 4 5}

Is MRI-guided high-dose radiation therapy generally safe for humans?

MRI-guided high-dose radiation therapy, also known as MRI-guided SBRT, has been used safely in treating both liver and prostate cancers. Studies have shown that it generally results in mild side effects, such as nausea and abdominal pain, and is well-tolerated by patients. ^{1 6 7 8 9}

How is MRI-guided High-dose Radiation Therapy different from other treatments for prostate cancer?

MRI-guided High-dose Radiation Therapy is unique because it uses MRI to precisely target the prostate, allowing for real-time tracking and adjustments during treatment. This approach can reduce the number of treatment sessions needed and minimize damage to surrounding healthy tissues compared to traditional CT-guided radiation therapy. ^{1 3 5 10 11}

Research Team

Victoria Brennan, MBBCH BAO

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Men over 18 with intermediate-risk prostate cancer can join this trial. They should have a PSA level of 10-20 ng/ml, Gleason score equal to 7, and clinical stage T2b/T2c. Their prostate size must be ≤80 cc with a visible lesion on MRI that's at least 0.5 cm. They need to be in good health (KPS ≥80), have mild urinary symptoms (IPSS ≤15), and meet specific MRI criteria without severe claustrophobia or metal implants that affect the scan.

Inclusion Criteria

I am 18 years old or older.

I can carry out normal activities with minimal symptoms.

My prostate is 80 cc or smaller.

Exclusion Criteria

PSA >20

I have a history of inflammatory bowel disease.

MRI findings: >2 disease foci identifiable

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive SBRT with a boost dose to the main tumor and standard dose to the rest of the prostate

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• MRI-guided High-dose Radiation Therapy (Proton Beam Therapy)

Trial Overview This study tests if giving a high 'boost' dose of radiation directly to the main tumor along with standard doses to the rest of the prostate is more effective in treating intermediate-risk prostate cancer than current methods. The goal is longer-lasting prevention of cancer return with minimal side effects.

Participant Groups

Group I: Prostate cancer patients Experimental Treatment 1 Intervention

Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate-risk patients will be defined as: * PSA 10-20 ng/ml or * Gleason score = 7 * Clinical stage T2b/T2c

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Findings from Research

Using MR-guided stereotactic body radiotherapy (SBRT) for prostate cancer showed that daily changes in patient anatomy had minimal impact on the radiation dose delivered, with prostate doses varying by only 0.5%.

The study analyzed data from four patients, indicating that the rectum and bladder also received minimal dose changes, mostly less than 0.5 Gy, which can inform strategies for daily online plan adaptation in MR-guided radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online adaptive planning for prostate stereotactic body radiotherapy using a 1.5 Tesla magnetic resonance imaging-guided linear accelerator. Yang, J., Vedam, S., Lee, B., et al.[2021]

In a phase 3 randomized clinical trial involving 156 men with localized prostate cancer, MRI-guided stereotactic body radiotherapy (SBRT) significantly reduced the incidence of acute grade 2 or greater genitourinary toxic effects compared to CT guidance (24.4% vs 43.4%; P=0.01).

MRI guidance also led to fewer gastrointestinal toxic effects and better patient-reported outcomes, with a lower percentage of patients experiencing significant increases in urinary symptoms and decreases in bowel quality of life scores at 1 month post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Guided vs Computed Tomography-Guided Stereotactic Body Radiotherapy for Prostate Cancer: The MIRAGE Randomized Clinical Trial. Kishan, AU., Ma, TM., Lamb, JM., et al.[2023]

In a study involving 10 patients with liver metastases, MR-guided stereotactic body radiotherapy (MRgSBRT) demonstrated excellent visibility of tumors without the need for fiducial markers, indicating a promising non-invasive treatment option.

The treatment was well-accepted by patients, with no reported cases of symptomatic radiation-induced liver disease after a median follow-up of 10 months, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marker-less online MR-guided stereotactic body radiotherapy of liver metastases at a 1.5 T MR-Linac - Feasibility, workflow data and patient acceptance. Gani, C., Boeke, S., McNair, H., et al.[2022]

In a study of 3410 patients treated with SBRT for localized prostate cancer, only 4.75% received treatment planning using CT alone, and this group showed tolerable toxicity with only two cases of Grade 3+ toxicity reported.

Quality of life assessments indicated temporary declines in urinary and bowel function after treatment in the CT group, but these returned to baseline levels in follow-up, suggesting that CT-based planning is a safe alternative for patients who cannot undergo MRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of stereotactic body radiation therapy for localized prostate cancer without treatment planning MRI. Amarell, K., Jaysing, A., Mendez, C., et al.[2022]

Stereotactic body radiation therapy (SBRT) using an MR-linac platform was successfully administered to 29 patients with minimal treatment delays, showing effective tumor response with most lesions either stable or reduced in size after treatment.

The use of MRI for real-time image guidance in SBRT resulted in lower liver doses and reduced toxicities, suggesting a safer treatment option for patients with hepatic tumors, although further studies are needed to fully assess the benefits and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time Magnetic Resonance-guided Liver Stereotactic Body Radiation Therapy: An Institutional Report Using a Magnetic Resonance-Linac System. Feldman, AM., Modh, A., Glide-Hurst, C., et al.[2023]

In a study involving 56 patients treated with Magnetic Resonance guided Radiotherapy (MRgRT) for primary liver tumors, no severe toxicities (greater than CTCAE grade 2) were observed, indicating a high safety profile for this treatment.

MRgRT achieved excellent local control rates of 98.1% at 12 months and 94.7% at 18 months, with an overall survival rate of 85.1% at 1 year, demonstrating its efficacy in managing primary liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective registry study of stereotactic magnetic resonance guided radiotherapy (MRgRT) for primary liver tumors. Bordeau, K., Michalet, M., Dorion, V., et al.[2023]

Prostate MRI is increasingly important in radiation therapy planning for prostate cancer, particularly in stereotactic body radiation therapy (SBRT), which delivers high doses of radiation in fewer sessions and is recognized as a valid treatment for various risk levels of prostate cancer.

MRI aids in reducing radiation exposure to sensitive areas like the urethra, thereby minimizing the risk of side effects, and helps in accurately targeting cancerous regions, which may enhance treatment effectiveness and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate MRI in Stereotactic Body Radiation Treatment Planning and Delivery for Localized Prostate Cancer. Nigogosyan, Z., Ippolito, JE., Collins, SP., et al.[2022]

The MIRAGE trial is a phase III randomized study involving 300 men with localized prostate cancer, comparing the safety and efficacy of MRI-guided versus CT-guided stereotactic body radiotherapy (SBRT) to determine which method results in lower acute genitourinary toxicity.

The primary goal is to assess the incidence of acute grade ≥2 genitourinary toxicity within the first 90 days post-treatment, with the hypothesis that MRI guidance will reduce toxicity compared to CT guidance, potentially leading to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided stereotactic body radiotherapy for prostate cancer (mirage): a phase iii randomized trial. Ma, TM., Lamb, JM., Casado, M., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Outcome of the first 200 patients with prostate cancer treated with MRI-Linac at Assuta MC. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Online adaptive planning for prostate stereotactic body radiotherapy using a 1.5 Tesla magnetic resonance imaging-guided linear accelerator. [2021]

3. Italy pubmed.ncbi.nlm.nih.gov

Adaptive SBRT by 1.5 T MR-linac for prostate cancer: On the accuracy of dose delivery in view of the prolonged session time. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Guided vs Computed Tomography-Guided Stereotactic Body Radiotherapy for Prostate Cancer: The MIRAGE Randomized Clinical Trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A randomized phase II trial of MR-guided prostate stereotactic body radiotherapy administered in 5 or 2 fractions for localized prostate cancer (FORT). [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Marker-less online MR-guided stereotactic body radiotherapy of liver metastases at a 1.5 T MR-Linac - Feasibility, workflow data and patient acceptance. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety of stereotactic body radiation therapy for localized prostate cancer without treatment planning MRI. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Real-time Magnetic Resonance-guided Liver Stereotactic Body Radiation Therapy: An Institutional Report Using a Magnetic Resonance-Linac System. [2023]

9. Ireland pubmed.ncbi.nlm.nih.gov

A prospective registry study of stereotactic magnetic resonance guided radiotherapy (MRgRT) for primary liver tumors. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Prostate MRI in Stereotactic Body Radiation Treatment Planning and Delivery for Localized Prostate Cancer. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided stereotactic body radiotherapy for prostate cancer (mirage): a phase iii randomized trial. [2021]