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

241 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

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 data supports the effectiveness of the treatment Hypofractionated Proton Beam Therapy for prostate cancer?

Research shows that hypofractionated proton therapy is effective for treating localized prostate cancer, with studies reporting positive outcomes over several years. It has been shown to be a feasible treatment option with manageable side effects compared to conventional methods. ^{1 2 3 4 5}

Is proton beam therapy safe for prostate cancer patients?

Proton beam therapy (PBT) for prostate cancer has been studied for its safety, showing low rates of serious side effects. Studies report that PBT can cause some mild to moderate side effects, but it generally preserves quality of life and is considered safe for treating prostate cancer. ^{4 6 7 8 9}

How is hypofractionated proton beam therapy different from other prostate cancer treatments?

Hypofractionated proton beam therapy for prostate cancer is unique because it uses a focused beam of protons to deliver radiation in fewer, larger doses, which can potentially reduce treatment time and minimize damage to surrounding healthy tissues compared to traditional radiation therapies. ^{1 3 10 11 12}

Research Team

Steven J. Frank

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A phase II study of hypofractionated proton therapy for prostate cancer. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Five-year outcomes from a prospective trial of image-guided accelerated hypofractionated proton therapy for prostate cancer. [2018]

3. Ireland 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Acute toxicity and patient-reported symptom score after conventional versus moderately hypofractionated proton therapy for prostate cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Four-Year Outcomes From a Prospective Phase II Clinical Trial of Moderately Hypofractionated Proton Therapy for Localized Prostate Cancer. [2020]

6. England 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. [2019]

7. United States 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. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Proton Beam Therapy Alone for Intermediate- or High-Risk Prostate Cancer: An Institutional Prospective Cohort Study. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Prostate bed irradiation with alternative radio-oncological approaches (PAROS) - a prospective, multicenter and randomized phase III trial. [2020]

10. Australia pubmed.ncbi.nlm.nih.gov

Extreme hypofractionated proton radiotherapy for prostate cancer using pencil beam scanning: Dosimetry, acute toxicity and preliminary results. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Impact of interfractional motion on hypofractionated pencil beam scanning proton therapy and VMAT delivery for prostate cancer. [2019]

12. Japan pubmed.ncbi.nlm.nih.gov

Acute toxicity of image-guided hypofractionated proton therapy for localized prostate cancer. [2018]