Proton Radiation Therapy for Prostate Cancer

Overseen By Pretesh Patel, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Bone metastasis, Distant lymph node metastasis, Previous prostate surgery, Prior radiotherapy, Uncontrolled illness, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6-8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat prostate cancer using proton beam therapy, which targets the cancer with precision to reduce damage to healthy tissues. The goal is to determine if this method can effectively treat high-risk prostate cancer or cases where cancer has spread to nearby lymph nodes, while minimizing side effects like stomach and bladder issues. The trial seeks participants with confirmed high-risk prostate cancer, such as those with a high Gleason score, seminal vesicle involvement, or elevated PSA levels. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in prostate cancer treatment.

Will I have to stop taking my current medications?

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 proton beam radiation therapy is safe for treating prostate cancer?

Previous studies have shown that proton beam radiation therapy is as safe as traditional radiation treatments. Research indicates that both proton and traditional radiation therapies offer similar safety and effectiveness. Specifically, one study found that 46% of patients treated with proton therapy were cancer-free after three years, compared to 49% with traditional radiation. This suggests both treatments yield similar outcomes in terms of safety.

Proton therapy targets tumors with greater precision, delivering radiation directly to the cancer while sparing nearby healthy tissues. This precision can potentially reduce side effects like stomach and urinary issues, which are common in prostate cancer treatments.

Overall, the data suggests that patients tolerate proton beam therapy well. Other studies have tested this treatment and shown promising safety results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Proton Beam Radiation Therapy is unique because it uses a precise form of radiation that targets prostate cancer more accurately than traditional radiation treatments like X-ray radiation. This precision means it can potentially reduce damage to surrounding healthy tissues and organs, leading to fewer side effects. Researchers are excited because this could allow for higher doses of radiation directly to the cancer cells, potentially improving treatment effectiveness and patient quality of life. Additionally, the optional high-dose rate brachytherapy boost and flexible androgen deprivation therapy offer tailored treatment approaches, which might enhance outcomes for individual patients.

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

Research has shown that proton therapy, which participants in this trial will receive, effectively treats prostate cancer. Studies indicate it offers strong tumor control and causes fewer side effects than traditional radiation methods. Proton therapy precisely targets the tumor, largely sparing healthy tissues, resulting in fewer digestive and urinary side effects for patients. Additionally, survival rates with proton therapy are promising, often matching or surpassing those of other radiation treatments. Experts agree that it is at least as effective as other standard radiation therapies for prostate cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Pretesh R. Patel

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for men with high-risk prostate cancer, confirmed by pathology, who haven't had radical surgery or prior radiotherapy. They should have a Gleason grade of 8 or higher and may have lymph node involvement but no distant metastasis or bone metastasis. Participants need to be in good enough health to consent and follow the trial procedures.

Inclusion Criteria

Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 60 days prior to registration on study)

Platelets >= 100,000 cells/mm^3 (obtained within 60 days prior to registration on study)

Patient must be able to provide study specific informed consent

Exclusion Criteria

I've had radiation treatment in the same area as my current cancer.

I do not have any major health issues that could interfere with the study.

My scans show no cancer spread to distant lymph nodes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo conventionally fractionated or hypofractionated proton beam therapy daily on Monday-Friday directed to the prostate, pelvic lymph nodes, and para-aortic lymph nodes. Patients may receive an optional high-dose rate brachytherapy boost.

6-8 weeks

Daily visits (Monday-Friday)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 1, 3, 6, 9, and 12 months, and 1.5, 2, 2.5, and 3 years.

3 years

Multiple visits over 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Proton Beam Radiation Therapy

Trial Overview The study is testing proton radiation therapy aimed at the prostate tumor and certain lymph nodes. It's compared with standard treatments to see if it can more effectively target tumors while causing fewer side effects like gastrointestinal and genitourinary issues.

How Is the Trial Designed?

Group I: Treatment (proton beam therapy) Experimental Treatment 4 Interventions

Patients undergo conventionally fractionated or hypofractionated proton beam therapy daily on Monday-Friday directed to the prostate, pelvic lymph nodes, and para-aortic lymph nodes. Patients may receive an optional high-dose rate brachytherapy boost. Androgen deprivation therapy is required but left to the discretion of the treating physician.

Proton Beam Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

Approved in United States as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

Approved in Canada as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

Approved in Japan as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

Approved in China as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

Approved in Switzerland as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 27,647 Medicare beneficiaries with prostate cancer, proton radiotherapy (PRT) was associated with lower genitourinary toxicity at 6 months compared to intensity-modulated radiotherapy (IMRT), but this difference disappeared by 12 months post-treatment.

PRT was significantly more expensive than IMRT, with median Medicare reimbursements of $32,428 for PRT compared to $18,575 for IMRT, yet no long-term differences in toxicity were observed between the two treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton versus intensity-modulated radiotherapy for prostate cancer: patterns of care and early toxicity. Yu, JB., Soulos, PR., Herrin, J., et al.[2022]

In a study of 180 prostate cancer patients treated between 1972 and 1979, those receiving a proton beam boost along with conventional x-ray therapy were able to receive a higher dose to the tumor without increasing side effects, demonstrating the safety of this approach.

Despite the increased dose delivered to the tumor using the proton beam, there were no significant differences in patient survival, disease-free survival, or local recurrence-free survival compared to those treated with conventional x-ray therapy, suggesting similar efficacy between the two methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protons or megavoltage X-rays as boost therapy for patients irradiated for localized prostatic carcinoma. An early phase I/II comparison. Duttenhaver, JR., Shipley, WU., Perrone, T., et al.[2019]

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 151 patients with organ-confined prostate cancer, proton beam therapy (PBT) demonstrated a low incidence of late Grade 2 or greater rectal toxicities, reported at only 2.0% after 2 years of follow-up.

The study indicates that PBT is a safe treatment option for localized prostate cancer, with minimal acute and late toxicities, suggesting it can effectively control side effects while delivering targeted radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-institutional Phase II study of proton beam therapy for organ-confined prostate cancer focusing on the incidence of late rectal toxicities. Nihei, K., Ogino, T., Onozawa, M., 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 1327 men treated with image-guided proton therapy for localized prostate cancer, the 5-year freedom from biochemical progression rates were very high, at 99% for low-risk, 94% for intermediate-risk, and 74% for high-risk patients, indicating strong efficacy of this treatment.

The treatment resulted in low rates of high-grade toxicities, with only 0.6% experiencing severe gastrointestinal issues and 2.9% facing severe genitourinary toxicity, suggesting that proton therapy is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-Year Biochemical Results, Toxicity, and Patient-Reported Quality of Life After Delivery of Dose-Escalated Image Guided Proton Therapy for Prostate Cancer. Bryant, C., Smith, TL., Henderson, RH., et al.[2020]

In a study involving 9 patients with localized prostate cancer, a method to retract the rectum during proton therapy significantly reduced the volume of the rectal wall receiving high radiation doses, which is crucial for minimizing side effects.

The use of a cylindrical rod to retract the rectum allowed for a proton boost treatment of 20 Gy, combined with conventional photon therapy, indicating a promising approach to enhance treatment efficacy while protecting surrounding organs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A method to separate the rectum from the prostate during proton beam radiotherapy of prostate cancer patients. Isacsson, U., Nilsson, K., Asplund, S., et al.[2018]

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]

In a study of 211 prostate cancer patients treated with image-guided proton therapy, early outcomes showed high efficacy with only 1.9% experiencing Grade 3 genitourinary (GU) symptoms and less than 0.5% experiencing Grade 3 gastrointestinal (GI) toxicities after a minimum follow-up of 2 years.

The need for pretreatment GU symptom management was linked to higher rates of posttreatment GU symptoms, indicating that managing symptoms before therapy may help reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early outcomes from three prospective trials of image-guided proton therapy for prostate cancer. Mendenhall, NP., Li, Z., Hoppe, BS., et al.[2022]

In a study of 295 men who underwent postoperative radiation therapy for prostate cancer, proton beam therapy (PBT) showed similar long-term disease control outcomes compared to intensity-modulated radiation therapy (IMRT) after a median follow-up of 59 months.

Both treatment modalities had comparable rates of biochemical failure, local failure, regional failure, distant failure, and all-cause mortality, indicating that PBT is as effective as IMRT in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Analysis of 5-Year Clinical Outcomes and Patterns of Failure of Proton Beam Therapy Versus Intensity Modulated Radiation therapy for Prostate Cancer in the Postoperative Setting. Barsky, AR., Carmona, R., Verma, V., et al.[2021]

In a study of 166 patients with favorable risk prostate cancer treated with proton beam therapy (PBT) over an average follow-up of 8.3 years, the biochemical failure-free survival (BFFS) rates were high, with 97% at 5 years and 92% at 8 years, indicating effective long-term disease control.

The study found very low rates of failure, with only 7.8% experiencing biochemical failure and no cases of distant failure, suggesting that PBT is a safe and effective primary treatment option for localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Clinical Outcomes in Favorable Risk Prostate Cancer Patients Receiving Proton Beam Therapy. Bao, A., Barsky, AR., Maxwell, R., et al.[2022]

Proton beam therapy (PBT) allows for higher doses of radiation to be delivered to prostate cancer tissues while minimizing damage to surrounding healthy tissues, making it a promising treatment option.

The review highlights the growing interest and advancements in PBT technology for localized prostate cancer, emphasizing the need for a deeper understanding of its application and treatment planning in radiation medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton beam therapy for the treatment of prostate cancer. Pugh, TJ., Choi, S., Nguyen, QN., et al.[2016]

Citations

1. floridaproton.org floridaproton.org/blog-spot/survival-rates-prostate-cancer

Survival rates for prostate cancer treated with proton therapy Proton therapy has shown promising results in treating prostate cancer, with high rates of tumor control and low rates of side effects.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489490/

Consensus Statement on Proton Therapy for Prostate Cancer Because of the relative biologic effectiveness (RBE) of proton therapy, it is predicted to be at least as effective in treating cancer as photon-based radiation ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7914293/

Overall Survival After Treatment of Localized Prostate Cancer ... PBT was associated with a significant overall survival benefit compared to EBRT and had a similar performance as BT.

4. emoryproton.com emoryproton.com/cancers-treated/prostate-cancer/

Proton Therapy for Prostate Cancer Treatment with proton beam therapy was associated with better 5-year overall survival than X-ray based external beam, and similar survival compared to ...

5. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2024/astro24efstathiou

IMRT and proton therapy offer equally high quality of life ... Multi-center, phase III trial finds photon- and proton-based radiation therapies similarly safe and effective.

6. cancer.gov cancer.gov/news-events/cancer-currents-blog/2020/proton-therapy-safety-versus-traditional-radiation

Is Proton Therapy Safer than Traditional Radiation? - NCI After 3 years, 46% of patients in the proton therapy group and 49% of those in the traditional radiation therapy group were cancer free. Fifty- ...

7. ascopost.com ascopost.com/issues/april-25-2025/proton-therapy-and-intensity-modulated-radiation-therapy-for-localized-prostate-cancer/

Proton Therapy and Intensity-Modulated Radiation ... Both treatments demonstrated excellent tumor control, with progression-free survival rates at 5 years of 93.7% (IMRT) and 93.4% (proton therapy) ...

8. tcr.amegroups.org tcr.amegroups.org/article/view/597/html

Proton beam radiation therapy of prostate cancer - Rossi With a median follow up of 43 months, the overall biochemical disease-free survival [bNED] rate was 79% as per the American Society for Therapeutic Radiology ...