Intensity-Modulated Radiotherapy for Prostate Cancer

Not currently recruiting at 7 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Metastatic disease, MRI ineligibility, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating prostate cancer using focused radiation called ultra-hypofractionated radiotherapy, a form of intensity-modulated radiotherapy. The trial aims to determine if this treatment is effective and manageable for individuals with intermediate-risk prostate cancer, which indicates a moderate chance of the cancer spreading or recurring. Advanced imaging guides the radiation to target the cancer more precisely. This trial may suit those diagnosed with intermediate-risk prostate cancer who have not undergone certain prior treatments or have conditions like severe urinary symptoms or significant prior prostate procedures. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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 prior data suggests that this radiotherapy technique is safe for prostate cancer treatment?

Research has shown that ultra-hypofractionated radiotherapy, an intense radiation treatment, is generally well-tolerated for prostate cancer. In one study using MRI guidance, most patients experienced only mild side effects, such as temporary fatigue and changes in urination, while serious side effects were rare.

Another study found that this treatment method led to survival rates similar to traditional treatments, without causing additional harm. These findings suggest that ultra-hypofractionated radiotherapy is both effective and safe for many patients.

While these results are promising, it's important to remember that this treatment is still under study. Prospective participants should discuss potential risks and benefits with their healthcare provider before joining a clinical trial for this therapy. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ultra-hypofractionated radiotherapy for prostate cancer because it offers a new approach to delivering radiation therapy. Unlike traditional methods that spread out treatment over several weeks, this technique delivers higher doses of radiation in fewer sessions, which could significantly reduce treatment time. Using MR-guided, intensity-modulated radiotherapy allows for more precise targeting of cancerous tissue, potentially minimizing damage to surrounding healthy tissues. This precision and efficiency are key reasons why this method is generating interest, as it could lead to better outcomes and improved quality of life for patients.

What evidence suggests that ultra-hypofractionated radiotherapy might be an effective treatment for prostate cancer?

Research shows that a new type of radiotherapy, called ultra-hypofractionated radiotherapy, holds promise for treating prostate cancer. In this trial, participants will undergo MR-based, image-guided, intensity-modulated radiotherapy. This method uses MRI scans to guide treatment, enabling doctors to target the cancer more precisely. In one study, all patients showed no signs of cancer returning after one year, based on blood tests. This treatment delivers a high dose of radiation in fewer sessions, offering convenience while maintaining effectiveness comparable to traditional methods. Early results suggest this approach is practical and could be highly effective for treating intermediate-risk prostate cancer. ^{1 3 5 6 7}

Who Is on the Research Team?

Daniel Gorovets, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Men over 18 with intermediate risk prostate cancer, defined by specific PSA levels, Gleason score, and clinical stage. They must have a dominant prostatic lesion of a certain size and no more than two smaller disease foci. Participants need good physical function (KPS > 80), prostate size < 60cc, manageable urinary symptoms, and must pass MRI screening without contraindications like metallic implants or severe claustrophobia.

Inclusion Criteria

My prostate cancer is at an intermediate risk level with specific PSA, Gleason score, or stage.

My prostate symptoms are mild.

Subjects must fill out the standard MRI screening form and satisfy all MRI screening criteria

Exclusion Criteria

My body size is too large for certain types of scans.

My scans show my cancer has spread to nearby tissues or lymph nodes.

My scans show cancer has spread to my bones.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants undergo MR-based, image-guided, intensity-modulated radiotherapy

6-8 weeks

Follow-up

Participants are monitored for treatment-related toxicity and effectiveness

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Ultra-hypofractionated Radiotherapy

Trial Overview

The trial is testing ultra-hypofractionated radiotherapy targeting the prostate and its main tumor site in men with intermediate-risk prostate cancer. The goal is to assess the treatment's feasibility and effectiveness as a definitive therapy using advanced MR-based imaging techniques for precise delivery.

How Is the Trial Designed?

Group I: MR Image Guided, Intensity-Modulated Radiotherapy Experimental Treatment 1 Intervention

Patients enrolled in this study will undergo MR-based, image-guided, intensity-modulated radiotherapy using similar equipment, techniques, and treatment-planning procedures as currently practiced at MSKCC.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In the HYPO-RT-PC trial involving 1180 patients with localized prostate cancer, ultra-hypofractionated radiotherapy showed higher acute toxicity compared to conventional fractionation, particularly in bowel symptoms, but long-term quality of life (QOL) was similar between the two treatment methods up to 6 years post-treatment.

Despite the initial increase in bowel-related issues for patients receiving ultra-hypofractionation, there were no significant differences in urinary, bowel, or sexual functioning between the two groups after the treatment period, indicating that ultra-hypofractionation is a viable option for patients with intermediate-to-high-risk prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer (HYPO-RT-PC): patient-reported quality-of-life outcomes of a randomised, controlled, non-inferiority, phase 3 trial. Fransson, P., Nilsson, P., Gunnlaugsson, A., et al.[2021]

In a study involving 457 men with localized prostate cancer, hypofractionated high-dose radiotherapy (60 Gy and 57 Gy) was found to be as well tolerated as conventional radiotherapy (74 Gy) over a median follow-up of 50.5 months, with low rates of grade 2 or worse bowel and bladder toxicities.

The rates of bowel toxicity were 4.3% for the conventional group, 3.6% for the 60 Gy group, and 1.4% for the 57 Gy group, indicating that hypofractionated treatment may not increase the risk of side effects compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial. Dearnaley, D., Syndikus, I., Sumo, G., et al.[2023]

In a study involving 874 men with localized prostate cancer, stereotactic body radiotherapy (SBRT) was found to have similar rates of acute gastrointestinal and genitourinary toxicity compared to conventionally fractionated or moderately hypofractionated radiotherapy, suggesting that shorter treatment courses do not increase immediate side effects.

The study showed that only 12% of patients receiving conventional treatment experienced severe gastrointestinal toxicity, compared to 10% in the SBRT group, and 27% versus 23% for genitourinary toxicity, indicating that SBRT is a safe alternative without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. Brand, DH., Tree, AC., Ostler, P., et al.[2022]

In a pilot study involving 24 patients with low- to intermediate-risk prostate cancer, highly hypofractionated intensity modulated radiation therapy (IMRT) delivered 54 Gy in 15 fractions over 3 weeks resulted in high survival rates: 91.7% biochemical relapse-free survival and 95.8% overall survival at 5 years.

The treatment was well-tolerated, with no severe late gastrointestinal or grade ≥3 genitourinary toxicities observed, suggesting that this approach may be a safe and effective alternative to traditional radiation therapy methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Outcomes of a Prospective Study on Highly Hypofractionated Intensity Modulated Radiation Therapy for Localized Prostate Cancer for 3 Weeks. Nakamura, K., Ikeda, I., Inokuchi, H., et al.[2023]

The Scandinavian HYPO-RT-PC trial, involving 1200 men with intermediate-to-high-risk prostate cancer, demonstrated that ultra-hypofractionated radiotherapy (42.7 Gy in seven fractions) is non-inferior to conventional fractionation (78.0 Gy in 39 fractions) in terms of failure-free survival over a median follow-up of 5 years.

While ultra-hypofractionation resulted in more acute urinary and bowel symptoms during treatment, late toxicity rates were similar to those of conventional fractionation, suggesting that ultra-hypofractionation is a safe and effective option for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Widmark, A., Gunnlaugsson, A., Beckman, L., et al.[2019]

Moderate hypofractionated radiotherapy for prostate cancer is associated with a 6.3% increase in acute grade ≥ 2 gastrointestinal toxicity compared to standard fractionation, indicating a need for careful monitoring and management of these symptoms.

There was no significant increase in acute genitourinary toxicity or late toxicity levels between moderate hypofractionation and standard fractionation, suggesting that while acute GI symptoms may be more common, overall safety profiles for late effects are similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and late toxicity patterns of moderate hypo-fractionated radiotherapy for prostate cancer: A systematic review and meta-analysis. Sinzabakira, F., Brand, V., Heemsbergen, WD., et al.[2023]

In a study of 194 patients with localized prostate cancer treated with ultra-hypofractionated radiotherapy, the 3-year biochemical progression-free survival (b-PFS) rate was 87%, with higher rates for low-risk patients (94%) compared to high-risk patients (66%).

The treatment was found to be safe, with acceptable levels of acute and long-term gastrointestinal and genitourinary toxicity, demonstrating that ultra-hypofractionated radiotherapy can effectively control tumors while minimizing impact on patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Give me five" ultra-hypofractionated radiotherapy for localized prostate cancer: non-invasive ablative approach. Marvaso, G., Riva, G., Ciardo, D., et al.[2018]

Citations

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We identified 16 publications that reported the use of ultrahypofractionated radiation therapy to treat the pelvis in prostate cancer. Seven publications met ...