Hypofractionated Radiotherapy for Prostate Cancer

Overseen By Harriet Eldredge-Hindy Eldredge-Hindy, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Must be taking: ADT

Must not be taking: Testosterone supplementation

Disqualifiers: Metastatic disease, Prior pelvic radiotherapy, 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: Unknown

Duration: 6 weeks

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new radiation treatment for men with previously untreated high-risk prostate cancer. Researchers are evaluating the safety and effectiveness of two new radiation techniques used together, including hypofractionated radiotherapy with focal microboost. Participants will attend regular check-ups, complete questionnaires, and provide blood samples. Men with prostate cancer fitting a specific risk profile—such as high PSA levels or certain Gleason scores—might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must stop using testosterone supplements before joining. It's best to discuss your specific medications with the trial team.

What prior data suggests that these radiation treatment techniques are safe for prostate cancer?

Previous studies have shown that hypofractionated radiotherapy with a focused microboost is quite safe for treating prostate cancer. Research indicates that patients did not experience severe side effects (grade 3 or higher) with this treatment, suggesting it is well-tolerated. The microboost technique targets extra radiation on specific areas and has been used safely, possibly improving treatment outcomes. Overall, both components of this treatment have been studied and appear to be safe options for prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Hypofractionated radiotherapy with a focal microboost is unique because it offers a new approach to treating prostate cancer by delivering higher doses of radiation in fewer sessions. Unlike the standard of care, which typically involves conventional fractionation over several weeks, this technique aims to complete treatment in a shorter timeframe, potentially reducing hospital visits and improving patient convenience. Researchers are excited about this treatment because it could enhance precision by targeting cancerous tissues more effectively while sparing healthy tissues, thereby minimizing side effects. This approach could lead to similar or even better outcomes compared to traditional methods, with a focus on improving patients' quality of life.

What evidence suggests that hypofractionated radiotherapy with focal microboost is effective for prostate cancer?

Research has shown that hypofractionated radiotherapy, which uses higher doses of radiation in fewer sessions, is as effective as traditional methods for treating prostate cancer. Studies have found that this approach helps prevent the cancer from worsening over time. Importantly, the treatment is generally safe, with no severe side effects reported in some studies. In this trial, participants will receive hypofractionated pelvic radiation with a focal microboost, which delivers extra radiation to specific areas. This technique aims to improve outcomes by targeting high-risk cancer spots. These findings suggest that combining both techniques could effectively treat high-risk prostate cancer. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adult men with high-risk or locally advanced prostate cancer that hasn't been treated before. They should have a PSA level over 20 ng/mL, a Gleason score of 8-10, and be staged as N1M0 (pelvic lymph node positive). Participants must be able to undergo pelvic radiotherapy and commit to the study schedule.

Inclusion Criteria

I can undergo pelvic radiotherapy and will follow the treatment plan.

I have prostate cancer and haven't had major treatments, but TURP over 90 days ago is okay.

My PSA level was over 20 ng/mL before starting hormone therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hypofractionated radiotherapy with a focal microboost for approximately 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up every three months for two years, then twice yearly for years 3-5

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiotherapy with Focal Microboost

Trial Overview

The trial tests hypofractionated radiation combined with a microboost technique on prostate cancer. It aims to assess safety and effectiveness compared to standard treatments. The study involves regular care visits, questionnaires, blood draws for research purposes, and optional tissue banking without extra biopsies.

How Is the Trial Designed?

Group I: Hypofractationed pelvic radiation with microboost Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07325721

Hypofractionated Radiotherapy With a Focal Microboost for ...

The purpose of this study is to evaluate the safety and effectiveness of the combination of two emerging radiation treatment techniques ( ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12751598/

Two-fraction Ultrahypofractionated Radiotherapy with focal ...

Hypofractionation in prostate cancer radiotherapy (RT) has drastically reduced fractionation schemes from 35 to 5 fractions for patients ...

3.

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 ...

4.

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 ...

5.

thelancet.com

thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00656-4/abstract

Ultra-hypofractionated versus conventionally fractionated ...

Impact of hypofractionated radiotherapy on patient-reported outcomes in prostate cancer: results up to 5 yr in the CHHiP trial (CRUK/06/016).

6.

advancesradonc.com

advancesradonc.com/article/S2452-1094(24)00192-1/fulltext

Microboost in Localized Prostate Cancer: Analysis of a ...

Prospective trials have reported isotoxicity and improved oncologic outcomes with external beam radiation therapy (EBRT) microboost to a dominant ...