Intensity-Modulated Radiotherapy for Prostate Cancer

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

35 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostrate cancer.

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 Ultra-hypofractionated Radiotherapy for prostate cancer?

The HYPO-RT-PC trial showed that ultra-hypofractionated radiotherapy is as effective as conventional radiotherapy in preventing cancer recurrence over five years, with similar side effects and patient-reported quality of life. ^{1 2 3 4 5}

Is Intensity-Modulated Radiotherapy for Prostate Cancer safe?

Intensity-Modulated Radiotherapy, including ultra-hypofractionated versions, is generally considered safe for treating prostate cancer, with acceptable levels of short-term and long-term side effects. Studies show that while there may be some increased short-term side effects, the treatment is well-tolerated and offers good control of the cancer. ^{6 7 8 9 10}

How is ultra-hypofractionated radiotherapy different from other prostate cancer treatments?

Ultra-hypofractionated radiotherapy for prostate cancer is unique because it delivers higher doses of radiation in fewer sessions compared to conventional treatments, making it more convenient and potentially cost-effective. Studies have shown it to be as effective as traditional methods in terms of survival and side effects, with the added benefit of a shorter treatment duration. ^{1 4 11 12 13}

Research Team

Daniel Gorovets, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

My prostate is smaller than 60cc.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

References

1. England 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. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Patterns of care for prostate cancer radiotherapy-results from a survey among German-speaking radiation oncologists. [2022]

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

Ten-Year Results From a Phase II Study on Image Guided, Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost in High-Risk Prostate Cancer. [2022]

4. United States 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. [2023]

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

Randomized Trial of Hypofractionated, Dose-Escalated, Intensity-Modulated Radiation Therapy (IMRT) Versus Conventionally Fractionated IMRT for Localized Prostate Cancer. [2022]

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

Acute and late toxicity patterns of moderate hypo-fractionated radiotherapy for prostate cancer: A systematic review and meta-analysis. [2023]

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

"Give me five" ultra-hypofractionated radiotherapy for localized prostate cancer: non-invasive ablative approach. [2018]

8. England 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. [2022]

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

Acute toxicity in high-risk prostate cancer patients treated with androgen suppression and hypofractionated intensity-modulated radiotherapy. [2018]

10. England 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. [2023]

11. England 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. [2019]

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

Rationale, conduct, and outcome using hypofractionated radiotherapy in prostate cancer. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Ultra-hypofractionated radiation therapy for unfavourable intermediate-risk and high-risk prostate cancer is safe and effective: 5-year outcomes of a phase II trial. [2023]