Hypofractionated Radiation Therapy for Prostate Cancer

Not currently recruiting at 8 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Androgen deprivation therapy

Disqualifiers: Metastasis, Prostatitis, Bowel disease, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy for prostate cancer, using higher doses over five sessions instead of the usual 45-48. The researchers aim to determine if this shorter treatment is safe and effective. It targets men with low or intermediate-risk prostate cancer, meaning their cancer is less aggressive and hasn't spread far. Participants should meet specific criteria for PSA levels (a protein made by the prostate) and Gleason scores (a measure of cancer aggressiveness). 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 approach.

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 ultra-hypofractionated IG-IMRT is safe for prostate cancer treatment?

Research shows that the type of radiation therapy tested in this trial is generally safe for prostate cancer patients. Previous studies have found that this treatment has a good safety record. For instance, one study reported no severe side effects in patients who received this therapy. Another study confirmed that the treatment works well and is easy for patients to handle, with no reports of serious unwanted effects.

These results suggest that the treatment in this trial is likely safe for participants. However, as this trial is still in its early stages, ongoing research will provide more detailed safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Hypofractionated radiation therapy is unique because it delivers higher doses of radiation over fewer sessions compared to traditional treatments for prostate cancer. This means patients can complete their treatment in a shorter time, reducing the overall disruption to their lives. Researchers are excited about this approach because it combines image-guided, intensity-modulated techniques to precisely target cancer cells, potentially improving treatment effectiveness while minimizing side effects. This could mean a more convenient and possibly more effective option for patients battling prostate cancer.

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

Research has shown that hypofractionated radiation therapy can effectively treat prostate cancer. One study found that patients with high-risk prostate cancer experienced good results with manageable side effects. Another study demonstrated that delivering radiation in shorter, more concentrated doses, as in hypofractionated therapy, successfully treated localized prostate cancer. Early trials have indicated that fewer treatment sessions can still be effective for prostate cancer patients. This trial will evaluate hypofractionated, image-guided, intensity-modulated external beam radiation therapy. These studies suggest that using higher doses of radiation in fewer treatments could be a promising approach to managing prostate cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Sean McBride, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Men aged 18 or older with low to intermediate risk prostate cancer, defined by specific PSA levels, Gleason scores, and clinical stages. They must have a good performance status (able to carry out daily activities), no severe urinary symptoms, a prostate size ≤60 cc, and no evidence of advanced disease on MRI/CT scans.

Inclusion Criteria

Eligibility is not restricted to MSKCC to confirm biopsy/diagnosis. Participating institution testing is sufficient

My prostate cancer is low risk with a PSA of 10 or less, Gleason score of 6, and stage T2a or lower.

My prostate cancer is at an intermediate stage with specific PSA levels and Gleason score.

Exclusion Criteria

I have a history of inflammatory bowel disease.

I am unable to understand and agree to the study's details on my own.

Unable to complete quality of life questionnaires

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive ultra-hypofractionated IG-IMRT with higher doses of radiation over 5 treatment days

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with the option for life-long follow-up at MSKCC

60 months

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated, image-guided, intensity-modulated external beam radiation

Trial Overview The trial is testing an advanced form of radiation therapy for prostate cancer called ultra-hypofractionated IG-IMRT. It involves fewer treatment sessions (5 over two weeks) with higher doses each time compared to the standard 45-48 treatments.

How Is the Trial Designed?

Group I: Radiation Experimental Treatment 1 Intervention

Patients enrolled in the study will undergo image-guided, intensity-modulated radiotherapy using the same equipment, techniques, and treatment-planning procedures as currently practiced as MSKCC. MSKCC patients will have the option of continued follow-up through MSKCC's established Prostate Survivorship Clinic for an indefinite period of time, meaning patients enrolled in the protocol will be encouraged to remain at MSKCC for life-long follow-up after their treatment. The standard assessments obtained in the Survivorship Clinic will not be altered. All protocol relevant data collected at these visits through month 60 will be used for protocol analysis.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Montefiore Medical Center

Collaborator

Trials

468

Recruited

599,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4261590/

Image guided intensity modulated hypofractionated ... The present study demonstrated that hypofractionated IGRT-IMRT-SIB in patients with high-risk prostate cancer is efficient with acceptable toxicity profile.

2. practicalradonc.org practicalradonc.org/article/S1879-8500(23)00175-3/fulltext

Long-Term Outcomes of a Prospective Study on Highly ... In this study, the efficacy and safety of highly hypofractionated IMRT in 15 fractions were evaluated for low- to intermediate-risk prostate ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3606774/

Hypofractionated External-Beam Radiotherapy for Prostate ... The preliminary results from clinical studies indicate that abbreviated fractionation programs can result in successful treatment of localized prostate cancer ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2331518024000817

Dosimetric Features of Ultra-Hypofractionated Intensity ... Hoppe, et al. Five-year outcomes from a prospective trial of image-guided accelerated hypofractionated proton therapy for prostate cancer. Acta Oncol ((Madr)) ...

5. redjournal.org redjournal.org/article/S0360-3016(18)31355-5/fulltext

Hypofractionated Intensity Modulated Radiation Therapy to ... We report 5-year outcomes for high-risk prostate cancer patients treated with androgen suppression and 20-fraction hypofractionated radiation therapy (HypoRT)

6. 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6000067/

Outcomes and toxicity from a prospective study of ... The purpose of this study is to report the long-term outcomes and toxicity results of a prospective trial of moderately hypofractionated, image guided ...

8. practicalradonc.org practicalradonc.org/article/S1879-8500(23)00175-3/pdf

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 ...

9. oncologynurseadvisor.com oncologynurseadvisor.com/features/moderately-hypofractionated-radiotherapy-in-prostate-cancer/

Hypofractionated Radiotherapy in Prostate Cancer Both isodose & dose-escalated MHFRT offer rates of progression-free & overall survival comparable to those seen with conventional ...