Hypofractionated Radiation Therapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Stage T3-4, Gleason 4+3, Metastases, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of radiation therapy to determine if it is as effective or better than the usual treatment for prostate cancer. The focus is on hypofractionation, where patients receive higher doses of radiation in fewer sessions. This method may suit individuals with localized prostate cancer, a low PSA level (a blood marker for prostate cancer), and who have chosen radiation therapy as their treatment. The goal is to assess whether this approach can control tumors effectively with fewer side effects. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for this trial?

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 radiation therapy regimen is safe for prostate cancer?

Research has shown that hypofractionated radiation therapy, which involves fewer but stronger doses of radiation, is generally safe for prostate cancer patients. In a large study, researchers reported no severe side effects, indicating that patients tolerate this treatment well. Another study found that this method offers similar survival rates to the traditional approach, without an increase in serious side effects. This type of radiation treatment has been tested in various situations, demonstrating promising safety and effectiveness for prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for prostate cancer?

Researchers are excited about hypofractionated radiation therapy for prostate cancer because it offers a faster treatment schedule compared to traditional radiation therapy. Unlike the standard approach, which typically involves smaller doses over several weeks, hypofractionation delivers higher doses of radiation in fewer sessions—specifically 16 sessions in this case. This method not only reduces the overall treatment time but also aims to maintain or even enhance the effectiveness against cancer cells. By potentially offering the same cancer control with less time commitment, it could improve patient convenience and reduce healthcare costs.

What evidence suggests that hypofractionated radiation therapy is effective for prostate cancer?

Studies have shown that hypofractionated radiation therapy effectively treats prostate cancer. In this trial, participants will receive this therapy, involving 3.6 Gy per day to a total dose of 57.6 Gy over 16 fractions. A large study found that patients who received this treatment experienced better long-term cancer control compared to traditional methods. Another analysis demonstrated that hypofractionation can achieve similar or even better results in slowing cancer growth and improving survival rates. Importantly, this approach may cause less harm to healthy cells, offering a safer option with fewer side effects. Overall, research suggests that hypofractionated radiation therapy is a promising and effective treatment for prostate cancer. ^{3 4 6 7 8}

Who Is on the Research Team?

Danny Song, MD

Principal Investigator

The Johns Hopkins University School of Medcine

Are You a Good Fit for This Trial?

Men with early-stage prostate cancer (Gleason score <7, PSA <10 ng/ml, stages T1a-T2b) who have chosen external beam radiation as their treatment can join. They must sign a consent form. Men with advanced cancer, high Gleason scores or PSA levels, previous major treatments for prostate cancer, other recent cancers (except certain skin/bladder cancers), inflammatory bowel disease, or serious medical/psychiatric issues cannot participate.

Inclusion Criteria

My prostate cancer is in an early stage and my PSA level is below 10 ng/ml.

My prostate cancer has a low Gleason score.

I have chosen external beam radiation to treat my prostate cancer.

Exclusion Criteria

My prostate cancer has a Gleason score of 7 or higher.

Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up

I have had chemotherapy or radiation therapy to the pelvis before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive hypofractionated radiation therapy with 3.6 Gy per day to a total dose of 57.6 Gy over 16 fractions

4 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after radiation therapy

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionation

Trial Overview The trial is testing a specific type of radiation therapy called hypofractionation to see if it's effective and safe in treating localized adenocarcinoma of the prostate. This Phase II study builds on earlier research suggesting that this approach could control tumors better than conventional therapy.

How Is the Trial Designed?

Group I: Hypofractionated radiation therapy in prostate adenocarcinoma Experimental Treatment 1 Intervention

Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).

Hypofractionation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Hypofractionation for:

• Soft tissue sarcomas
• Extremity soft tissue sarcomas
• Trunk soft tissue sarcomas

Approved in United States as Hypofractionation for:

• Soft tissue sarcomas
• Extremity soft tissue sarcomas
• Trunk soft tissue sarcomas

Approved in Canada as Hypofractionation for:

• Soft tissue sarcomas
• Extremity soft tissue sarcomas
• Trunk soft tissue sarcomas

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Published Research Related to This Trial

In a study of 41 patients with high-risk localized prostate cancer, combining whole-pelvis irradiation with a stereotactic body radiotherapy (SBRT) boost resulted in a high 4-year biochemical failure-free survival rate of 91.9%, indicating effective cancer control.

The treatment was associated with minimal toxicity, with no severe (grade 3) gastrointestinal or genitourinary side effects reported, suggesting that this approach is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. Lin, YW., Lin, LC., Lin, KL.[2020]

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 of 820 patients with localized prostate cancer, hypofractionated radiation therapy showed similar 5-year relapse-free survival rates compared to conventional radiation therapy, but it did not demonstrate noninferiority in terms of genitourinary and gastrointestinal quality of life.

While hypofractionation did not perform as well for urinary and gastrointestinal symptoms, it was found to be noninferior for other aspects of quality of life, such as symptoms related to androgen deprivation therapy and sexual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate Hypofractionation in Intermediate- and High-Risk, Localized Prostate Cancer: Health-Related Quality of Life From the Randomized, Phase 3 HYPRO Trial. Wortel, RC., Oomen-de Hoop, E., Heemsbergen, WD., et al.[2019]

Recent evidence suggests that hypofractionated radiotherapy for prostate cancer is both safe and effective, particularly with a recommended regimen of 60 Gy in 20 fractions, which showed no significant increase in late toxicity.

While moderate hypofractionation has demonstrated positive 5-year outcomes in large trials, further research is needed for extreme hypofractionation techniques, and their use should currently be restricted to clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionation for prostate cancer: an update. Tiberi, D., Vavassis, P., Nguyen, D., 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]

Hypofractionated radiotherapy for prostate cancer, which delivers larger doses in fewer sessions, has shown improved biochemical control of the disease, supported by multiple clinical trials.

Advanced radiation techniques like 3D conformal radiotherapy and intensity modulated radiation therapy enable higher doses to the prostate while protecting surrounding healthy tissues, making hypofractionation a safer and more effective option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of hypofractionated radiotherapy for prostate cancer. Spyropoulou, D., Kardamakis, D.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20934277/

final results of phase III randomized trial The biochemical relapse-free, but not overall, survival at 90 months was significantly better with the hypofractionated (53%) than with the ...

2. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00034-8/abstract

Hypofractionated radiotherapy for prostate cancer (HYDRA) Hypofractionated radiotherapy for prostate cancer (HYDRA): an individual patient data meta-analysis of randomised trials in the MARCAP consortium.

3. 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 ...

4. 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 ...

5. mdpi.com mdpi.com/2673-592X/4/4/29

Exploring Hypofractionated Radiotherapy Efficacy in ... The findings indicate that hypofractionation may help preserve non-cancerous cells while potentially improving outcomes for aggressive prostate cancer types.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12077468/

Hypofractionated radiotherapy for localized prostate cancer This trial aims to investigate the safety outcomes of HFRT in 15 fractions for treating patients with localized PCa.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01444820

Study Details | NCT01444820 | Hypofractionated, Dose ... The primary outcome of the study is the acute and delayed toxicity and the secondary outcomes include biochemical failure, prostate specific mortality rate, ...

8. e-roj.org e-roj.org/journal/view.php?year=2024&vol=42&spage=171

Part 3. Genitourinary and gynecological cancers Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised ...