Short-Course Proton Radiation for Prostate Cancer

Not currently recruiting at 6 trial locations

Overseen By Matthew Morocco, BS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Proton Collaborative Group

Must not be taking: Anticoagulants

Disqualifiers: Prostatectomy, Pelvic radiation, Crohn's, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1-9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of radiation treatments for prostate cancer to determine their effectiveness. One group will receive traditional proton radiation treatment over several weeks, while the other group will undergo a shorter, more intense proton radiation treatment over one to two weeks. The study seeks men with prostate cancer who have a Gleason score between 2-6 and a PSA level under 10. Participants should not have had previous prostate surgery or radiation treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in prostate cancer treatment.

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 cannot continue anticoagulation medications like warfarin or heparin during the study unless they can be paused for certain procedures.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both proton radiation hypofractionation and standard fractionation are generally safe for treating prostate cancer. Hypofractionation involves fewer treatment sessions with a higher dose each time. Studies have found it safe and effective for patients with low- and intermediate-risk prostate cancer, with early side effects similar to those of standard treatment.

Standard fractionation requires more sessions with a lower dose each time. Proton therapy, used for many years, is considered safe and usually causes fewer urinary side effects than photon therapy, another type of radiation. Patients generally tolerate it well.

In summary, both treatment options have a good safety record based on research. They are generally well-tolerated, with side effects that most patients can manage. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about proton radiation hypofractionation for prostate cancer because it delivers a higher dose of radiation in fewer sessions—just five instead of the standard 44. This approach potentially shortens the overall treatment time significantly while targeting cancer cells with precision, reducing exposure to surrounding healthy tissues. Additionally, proton radiation's unique ability to deposit energy directly at the tumor site minimizes side effects compared to traditional radiation therapies like IMRT or brachytherapy. These features make it an attractive option for improving patient convenience and comfort without compromising effectiveness.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will compare two approaches to proton radiation for treating prostate cancer: hypofractionation and standard fractionation. Research has shown that proton radiation effectively treats prostate cancer. The hypofractionation approach, involving fewer sessions with a higher dose of radiation, works well for patients with low- and intermediate-risk prostate cancer and is as safe as other radiation methods. The standard fractionation approach, which involves more sessions with a lower dose, has also proven effective, with very few patients experiencing severe side effects. Both methods show promise, and this trial aims to compare their effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Carlos Vargas, MD

Principal Investigator

Proton Collaborative Group

Are You a Good Fit for This Trial?

Men over 18 with low-risk prostate cancer, confirmed within the last year, can join. They should be in good physical shape (able to walk and care for themselves), have a Gleason score of 2-6, PSA under 10 ng/ml, and no history of certain prostate treatments or pelvic radiation. No major health issues that could affect participation are allowed.

Inclusion Criteria

My prostate cancer was confirmed by a lab test within the last year.

My pelvic lymph nodes are not enlarged over 1.5 cm, or if they are, they've been tested and are not cancerous.

My PSA level was below 10 ng/ml within the last 3 months.

Exclusion Criteria

I have active inflammation or infection in my rectum due to diverticulitis, Crohn's disease, or ulcerative colitis.

I am currently on blood thinners that can be paused for treatment if necessary.

I have received chemotherapy for prostate cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard-fractionation (44 treatments over 8½-9 weeks) or hypo-fractionation (5 treatments over 1-2 weeks) with proton radiation therapy

1-9 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on 2-year freedom from failure (FFF) and other outcomes

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Proton Radiation Hypofractionation
• Proton Radiation Standard Fractionation

Trial Overview This study tests two ways of giving proton radiation therapy for prostate cancer: the standard way with 44 treatments over about 9 weeks versus a higher daily dose given in just 5 treatments over one to two weeks. The goal is to see if the shorter treatment works as well or better.

How Is the Trial Designed?

Group I: Proton Radiation Hypofractionation Experimental Treatment 1 Intervention

5 fractions (7.6 Gy(RBE) x 5)

Group II: Proton Radiation Standard Fractionation Active Control 1 Intervention

44 fractions (1.8 Gy(RBE) x 44)

Who Is Running the Clinical Trial?

Proton Collaborative Group

Lead Sponsor

Trials

10

Recruited

41,100+

Published Research Related to This Trial

In a study of 289 prostate cancer patients, hypofractionated proton beam therapy (PBT) showed no significant differences in acute adverse event rates or quality of life, as measured by the International Prostate Symptom Score (IPSS), compared to conventionally fractionated PBT.

The study evaluated patients treated with different doses (2.0, 2.5, and 3.0 Gy RBE per fraction) and found that factors like diabetes, age, and androgen deprivation therapy did not influence the IPSS outcomes, suggesting that hypofractionated PBT is a safe option without increased toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity and patient-reported symptom score after conventional versus moderately hypofractionated proton therapy for prostate cancer. Iizumi, T., Ishikawa, H., Sekino, Y., et al.[2022]

In a study involving 200 patients with early-stage prostate cancer, extreme hypofractionated proton therapy (36.25 GyE in five fractions) demonstrated feasibility with a low rate of acute toxicity, where no patients experienced severe (G3) side effects.

After a median follow-up of 36 months, the treatment showed promising effectiveness, with no local recurrences of cancer and a low PSA relapse rate of 1.08% in low-risk and 6.5% in intermediate-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extreme hypofractionated proton radiotherapy for prostate cancer using pencil beam scanning: Dosimetry, acute toxicity and preliminary results. Kubeš, J., Vondráček, V., Andrlik, M., et al.[2020]

A study involving 531 patients with localized prostate cancer showed that a hypofractionated proton boost of 20 Gy followed by photon therapy was effective, achieving 5-year PSA relapse-free survival rates of 100% for low-risk and 72% for very high-risk patients.

The treatment demonstrated a low toxicity profile, with only 2% of patients experiencing grade 3 or higher genitourinary toxicity and 0% gastrointestinal toxicity, indicating that this approach is safe even for patients with higher risk and larger prostate volumes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High efficacy of hypofractionated proton therapy with 4 fractions of 5 Gy as a boost to 50 Gy photon therapy for localized prostate cancer. Johansson, S., Isacsson, U., Sandin, F., et al.[2020]

The PAROS trial is a large-scale, multicenter phase III study involving 897 post-prostatectomy patients, comparing the effects of hypofractionated radiotherapy (hRT) with photons and protons against standard normofractionated radiotherapy (nRT) to assess improvements in bowel-related quality of life after treatment.

The primary goal is to determine if proton therapy leads to better bowel scores compared to photon therapy, while also evaluating the non-inferiority of hRT in terms of biochemical progression-free survival, overall survival, quality of life, and toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate bed irradiation with alternative radio-oncological approaches (PAROS) - a prospective, multicenter and randomized phase III trial. Koerber, SA., Katayama, S., Sander, A., et al.[2020]

Hypofractionated proton therapy (PT) for prostate cancer is feasible and shows an acceptable toxicity profile, with acute gastrointestinal (GI) toxicity at 0% and acute genitourinary (GU) toxicity at 5% among 82 patients studied over a median follow-up of 42 months.

The four-year biochemical control free survival (BCFFS) rates were 85% and 86%, indicating that hypofractionated PT is as effective as conventional treatments, potentially offering patients a more efficient and cost-effective option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of hypofractionated proton therapy for prostate cancer. Kim, YJ., Cho, KH., Pyo, HR., et al.[2022]

In a study of 526 patients with localized prostate cancer, hypofractionated proton therapy (HFPT) showed significantly lower rates of acute genitourinary toxicity compared to conventional fractionated proton therapy (CFPT), with grade 2 toxicity rates of 5.9% for HFPT versus 15% for CFPT.

Both treatment methods were safe, as no severe (grade ≥3) acute toxicities were reported, indicating that HFPT is a promising option for patients with localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity of image-guided hypofractionated proton therapy for localized prostate cancer. Nakajima, K., Iwata, H., Ogino, H., et al.[2018]

In a study of 82 low-risk prostate cancer patients, those treated with hypofractionated proton-beam therapy (38 Gy in 5 treatments) and standard fractionation (79.2 Gy in 44 treatments) showed similar quality of life and urinary, bowel, and sexual function scores over 24 months.

Both treatment groups experienced excellent tolerance with no severe adverse events (grade 3 or higher), indicating that proton therapy is a safe option for prostate cancer treatment with comparable efficacy between the two fractionation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Versus Standard Fractionated Proton-beam Therapy for Low-risk Prostate Cancer: Interim Results of a Randomized Trial PCG GU 002. Vargas, CE., Hartsell, WF., Dunn, M., et al.[2019]

In a study of 215 prostate cancer patients treated with image-guided accelerated hypofractionated proton therapy, the 5-year rates of freedom from disease progression were very high, at 95.9% overall, indicating strong efficacy of this treatment approach.

The treatment resulted in minimal severe toxicities, with only 0.5% experiencing significant gastrointestinal issues and 1.7% facing severe urologic toxicities, suggesting that this therapy is safe for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year outcomes from a prospective trial of image-guided accelerated hypofractionated proton therapy for prostate cancer. Henderson, RH., Bryant, C., Hoppe, BS., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10526468/

5-Years Analysis of Effectivity and Toxicity of Ultra- ... Ultra-hypofractionated proton radiotherapy using PBS is highly effective in the treatment of low- and intermediate-risk prostate cancer. We ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2331518023001300

Hypofractionated Proton Therapy in Early Prostate Cancer Hypofractionated proton therapy of 60 Gy in 20 fractions was safe and effective for patients with low-risk prostate cancer.

3. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)00186-5/abstract

Photon vs proton hypofractionation in prostate cancer Conclusion. The present study supports that PT is safe and effective for localized PCa treatment, however, more data from RCTs are needed to draw solid evidence ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38561122/

Photon vs proton hypofractionation in prostate cancer The present study supports that PT is safe and effective for localized PCa treatment, however, more data from RCTs are needed to draw solid ...

5. mdproton.com mdproton.com/advances-in-prostate-cancer-therapy-the-efficacy-of-hypofractionation-and-proton-therapy/

Advances in Prostate Cancer Therapy: The Efficacy of ... With hypofractionation, the treatment period is reduced by nearly 50% to four to six weeks. Advancing even further, studies are underway to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9425455/

comparison of acute toxicity and early quality of life outcomes Moderately hypofractionated proton therapy has an acceptable early safety profile. Acute toxicity and QoL outcomes are not inferior to normofractionated proton ...

7. foxchase.org foxchase.org/news/2021-04-09-research-comparing-radiation-therapies-show-they-are-safe-for-prostate-cancer-patients

Research Comparing Radiation Therapies Show They Are ... The findings demonstrate that moderate hypofractionation is safe when used to treat patients with low- or intermediate-risk prostate cancer, ...