Hypofractionated Proton Therapy for Prostate Cancer

Recruiting at 1 trial location

Overseen By Brenda J Whitehead, CCRP

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Provision Center for Proton Therapy

Must not be taking: Chemotherapy

Disqualifiers: AIDS, Distant metastases, others

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

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

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

235 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new approach to treating prostate cancer using hypofractionated proton therapy, which involves fewer, more intense radiation sessions. The goal is to determine if this method is as effective as traditional proton therapy while offering greater convenience and cost-effectiveness. Researchers will also compare side effects, such as digestive and urinary issues. Men diagnosed with prostate cancer within the last year, who have not received previous radiation or prostate cancer treatment, might be suitable candidates for this trial. As an unphased trial, this study provides patients the opportunity to contribute to groundbreaking research that could lead to more convenient treatment options.

Do I need to stop my current medications to join the 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 hypofractionated proton therapy is safe for prostate cancer patients?

Research has shown that hypofractionated proton therapy is generally safe for prostate cancer patients. One study found that a dose of 60 Gy over 20 treatments was effective and well-tolerated by patients with low-risk prostate cancer. Another report noted a low rate of late side effects in patients who received a slightly higher dose. Although some studies suggest it is well-tolerated, more research is needed to fully understand its safety. Overall, current evidence suggests this therapy has a manageable safety profile for treating prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Hypofractionated Proton Therapy is unique because it delivers higher doses of radiation in fewer sessions compared to traditional radiation therapy for prostate cancer. This method uses proton beams, which can be targeted more precisely to the tumor, potentially sparing surrounding healthy tissues and reducing side effects. Researchers are excited about this approach because it combines the precision of proton therapy with the convenience of a shorter treatment duration, which could improve patient quality of life and outcomes.

What evidence suggests that hypofractionated proton therapy could be effective for prostate cancer?

Research has shown that hypofractionated proton therapy is a safe and effective treatment for prostate cancer. In this trial, participants with low-risk prostate cancer will receive hypofractionated proton therapy at 62 Gy (RBE) in 20 fractions over 4 weeks. One study found that administering 60 Gy in 20 sessions worked well for patients with low-risk prostate cancer. Another study found that this treatment also produced good results for higher-risk prostate cancer, with promising long-term outcomes. Patients generally tolerated this therapy well. While researchers continue to gather strong evidence, these findings suggest that hypofractionated proton therapy is a promising option for treating prostate cancer. ^{2 4 6 7 8}

Who Is on the Research Team?

J. Ben Wilkinson, M.D.

Principal Investigator

Provision Center for Proton Therapy

Are You a Good Fit for This Trial?

Men over 18 with low or intermediate risk prostate cancer, PSA <20 ng/mL, ECOG status 0-1, no evidence of distant metastases or regional lymph node involvement. Eligible patients must have a Gleason Score <7 and clinical stage T1-T2c. Prior systemic therapy for prostate cancer disqualifies participation.

Inclusion Criteria

I have had a physical exam to determine the stage of my prostate cancer.

I was diagnosed with prostate cancer in the last year.

Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis

Exclusion Criteria

I have received chemotherapy for prostate cancer.

My cancer has spread to distant parts of my body.

I have had treatments like surgery, cryotherapy, or hyperthermia for prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hypofractionated proton therapy, 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks

4 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life outcomes after treatment

5 years

Every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Proton Therapy

Trial Overview The trial is testing moderate hypofractionated proton therapy against conventional regimens in treating low and intermediate risk prostate cancer. It aims to compare quality of life outcomes and early/late gastrointestinal/genitourinary toxicities.

How Is the Trial Designed?

Group I: Low Risk Prostate Cancer Active Control 1 Intervention

Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks

Group II: Intermediate Risk Prostate Cancer Active Control 1 Intervention

Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks

Hypofractionated Proton Therapy is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Proton Therapy for:

• Prostate cancer
• Brain tumors
• Spinal cord tumors
• Head and neck cancers
• Retroperitoneal sarcomas

Approved in European Union as Proton Therapy for:

• Prostate cancer
• Brain tumors
• Spinal cord tumors
• Head and neck cancers
• Eye tumors

Approved in Japan as Proton Therapy for:

• Prostate cancer
• Brain tumors
• Spinal cord tumors
• Head and neck cancers
• Pediatric cancers

Who Is Running the Clinical Trial?

Provision Center for Proton Therapy

Lead Sponsor

Trials

3

Recruited

990+

Center for Biomedical Research, LLC

Collaborator

Trials

2

Recruited

540+

Published Research Related to This Trial

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 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]

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]

In a study of 1850 patients with early-stage prostate cancer, both moderately hypofractionated proton beam therapy (PBT) and intensity modulated radiation therapy (IMRT) resulted in low rates of late genitourinary (GU) and gastrointestinal (GI) toxicity, indicating that both treatments are safe options.

There was no significant difference in late toxicity rates between PBT and IMRT, with late grade 3+ GU toxicity at 2.0% for PBT and 3.9% for IMRT, and late grade 2+ GI toxicity at 14.6% for PBT and 4.7% for IMRT, suggesting both modalities are equally effective in minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pooled Toxicity Analysis of Moderately Hypofractionated Proton Beam Therapy and Intensity Modulated Radiation Therapy in Early-Stage Prostate Cancer Patients. Vapiwala, N., Wong, JK., Handorf, E., et al.[2022]

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 (HFPT) for localized prostate cancer showed a high biochemical-clinical failure-free survival rate of 93.5% after four years, indicating its efficacy as a treatment option.

The treatment was associated with low rates of acute and late toxicities, with only 3.8% experiencing significant gastrointestinal issues and 12.5% urologic issues, and no long-term negative effects on urinary or bowel health reported by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four-Year Outcomes From a Prospective Phase II Clinical Trial of Moderately Hypofractionated Proton Therapy for Localized Prostate Cancer. Grewal, AS., Schonewolf, C., Min, EJ., 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]

Citations

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

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

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39672515/

Five-Year Outcomes of Moderately Hypofractionated ... This regimen of moderately hypofractionated IMPT for HR or UIR-PCa yielded encouraging 5-year RFR, DFS, and late AE outcomes.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11907720/

A pooled patient-reported outcomes analysis of moderately ... This multi-institutional cohort analysis of prostate cancer PRQOL outcomes demonstrated that moderately hypofractionated PBT and IMRT were well tolerated with ...

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

Photon vs proton hypofractionation in prostate cancer High-level evidence on hypofractionated proton therapy (PT) for localized and locally advanced prostate cancer (PCa) patients is currently missing.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02040610

NCT02040610 | Hypofractionated Image Guided Proton ... This study is being proposed to evaluate the use of moderate hypofractionated proton therapy in low and intermediate risk prostate cancer patients. Quality of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38739903/

5-year outcomes of a phase II trial The current study revealed a low incidence of late adverse events in prostate cancer patients treated with moderately hypofractionated PBT of 70 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9104796/

The Role of Hypofractionation in Proton Therapy - PMC Many of the reported clinical data indicate that hypofractionated PBT can be well tolerated, however future clinical trials are still needed to ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04190446

A Study to Evaluate Hypofractionated Proton Therapy or ... Hypofractionated proton beam radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects.