Proton Beam Therapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Invasive malignancy, Metastases, Lymph node involvement, others

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

Compensation: Varies

Number of Visits: 6

Duration: 5-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation therapy called proton beam therapy for prostate cancer that hasn't spread beyond the prostate. The goal is to determine if this treatment can kill more cancer cells while causing less harm to healthy tissue. Suitable candidates have a recent prostate cancer diagnosis confirmed at MD Anderson, a Gleason score between 2 and 7, and no other cancer history in the past five years. Participants will undergo hypofractionated proton beam therapy sessions over 5-6 weeks. 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 new therapy.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, patients on blood thinning agents like Coumadin are eligible to participate, suggesting some medications may be allowed.

What prior data suggests that hypofractionated proton beam therapy is safe for prostate cancer patients?

Research has shown that hypofractionated proton beam therapy is generally safe for treating prostate cancer. One study found that this therapy led to fewer urinary problems compared to traditional photon therapy, resulting in fewer issues with urination for patients. Another study demonstrated that this therapy was safe and effective for men with low-risk prostate cancer.

While these results are encouraging, further research is needed to confirm its long-term safety. Overall, the therapy appears well-tolerated and has fewer side effects than some other treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Hypofractionated Proton Beam Therapy is unique because it uses focused proton beams to target prostate cancer cells more precisely than traditional radiation therapies. Unlike standard treatments, like conventional X-ray radiation, this therapy delivers higher doses of radiation in fewer sessions, potentially reducing overall treatment time to just 5-6 weeks. Researchers are excited about this approach because its precision minimizes damage to surrounding healthy tissues, which might lead to fewer side effects and improved quality of life for patients.

What evidence suggests that hypofractionated proton beam therapy might be an effective treatment for prostate cancer?

Studies have shown that hypofractionated proton beam therapy, which participants in this trial will receive, effectively treats prostate cancer. One study found this therapy safe and effective for patients with low-risk prostate cancer. Another study demonstrated that a more intense version, ultra-hypofractionated proton therapy, worked well for both low- and intermediate-risk prostate cancer, reducing treatment time by about half. This treatment also caused fewer side effects compared to traditional radiation methods. Overall, research suggests that this approach can precisely target tumors, minimizing harm to healthy tissue. ^{1 2 3 5 6}

Who Is on the Research Team?

Steven J. Frank

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Men with early-stage prostate cancer (Gleason score 2-7, stage T1-2b) and PSA <20 ng/mL can join this trial. They must have had a physical exam within the last 90 days and be in good health overall (Zubrod performance status 0-1). Prior invasive cancers, metastases, lymph node involvement, previous prostate surgeries or radiation treatments disqualify participation.

Inclusion Criteria

Willingness and ability to complete the EPIC questionnaire

My prostate cancer was confirmed through a biopsy within the last year.

I have had a prostate exam in the last 90 days.

Exclusion Criteria

My cancer has spread to nearby lymph nodes.

I have been cancer-free for at least 5 years, except for non-melanoma skin cancer or blood cancers.

My cancer has spread to distant parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks

5-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Every 6-12 months for 24 months, then annually until month 60

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Proton Beam Therapy

Trial Overview The study is testing hypofractionated proton beam therapy's effectiveness and side effects on localized prostate cancer. It involves delivering high doses of targeted radiation to minimize damage to healthy tissue. Participants will also undergo lab biomarker analysis and quality-of-life assessments.

How Is the Trial Designed?

Group I: Treatment (proton beam radiation therapy) Experimental Treatment 3 Interventions

Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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 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]

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 of 192 prostate cancer patients treated with proton beam therapy (PBT) over a median follow-up of 1.7 years, only 5 patients experienced grade 3 toxicity, with no occurrences of grade 4 or 5 toxicity, indicating a high safety profile for this treatment.

Patient-reported outcomes showed stable urinary function post-treatment, while sexual health scores declined slightly at 1 year but did not worsen thereafter; bowel function scores also decreased but stabilized, suggesting manageable side effects associated with PBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early toxicity and patient reported quality-of-life in patients receiving proton therapy for localized prostate cancer: a single institutional review of prospectively recorded outcomes. Lee, HJ., Macomber, MW., Spraker, MB., et al.[2019]

Proton beam therapy (PBT) as a standalone treatment for localized prostate cancer showed a high 5-year progression-free survival rate of 97% for intermediate-risk patients and 83% for high-risk patients, indicating its efficacy.

The treatment was associated with low rates of severe side effects, with only 3.9% of patients experiencing significant gastrointestinal toxicity and 23.5% experiencing acute genitourinary toxicity, suggesting that PBT can effectively preserve patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Beam Therapy Alone for Intermediate- or High-Risk Prostate Cancer: An Institutional Prospective Cohort Study. Arimura, T., Yoshiura, T., Matsukawa, K., 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 (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]

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 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 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]

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]

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. 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 ...

4. 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 ...

5. tandfonline.com tandfonline.com/doi/full/10.2147/CMAR.S546959

Hypofractionated Radiotherapy for Prostate Cancer Proton therapy was associated with reduced GU toxicity compared to photon therapy, based on assessments from both physicians and patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01950351

Hypofractionated Proton Beam Therapy for Localized ... This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that ...