Proton Therapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Cincinnati

Must not be taking: Androgen deprivation therapy

Disqualifiers: High risk prostate cancer, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treating prostate cancer by combining photon radiation with a special proton boost, a type of proton therapy. Researchers aim to determine if the proton boost reduces side effects compared to photon radiation alone. They also seek to assess the treatment's effectiveness in preventing cancer recurrence and increasing survival. Men with low to intermediate-risk prostate cancer who have not undergone hormone therapy or previous prostate cancer treatments may be suitable candidates. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could lead to improved treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using androgen deprivation therapy, you would not be eligible to participate.

What prior data suggests that proton therapy is safe for prostate cancer treatment?

Research has shown that proton therapy, like the proton boost under study, is generally safe and well-tolerated for treating prostate cancer. One study found that 45 months after treatment, men who received proton therapy with a low-dose radiation boost had high rates of cancer control and experienced fewer harmful side effects.

Another study indicated that early results with proton therapy for high-risk prostate cancer patients were promising in terms of safety. Proton therapy targets the tumor more precisely, which helps protect nearby healthy tissues and organs. This precision reduces the risk of unwanted side effects.

In summary, current findings suggest that proton therapy is a safe option for treating prostate cancer, with fewer side effects compared to traditional radiation methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about proton therapy for prostate cancer because it offers a more precise delivery of radiation compared to traditional photon therapy. Proton therapy uses charged particles that can be controlled more accurately, potentially reducing damage to surrounding healthy tissues. This precision means that higher doses of radiation can be delivered directly to the tumor, which might improve treatment outcomes and reduce side effects. Unlike standard photon therapy, which passes through the body, proton therapy stops at the tumor site, providing a targeted approach that could be game-changing for patients.

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

This trial will evaluate the effectiveness of proton therapy for prostate cancer. Studies have shown that proton therapy can effectively treat prostate cancer by accurately targeting tumors while sparing healthy tissue, which helps reduce side effects. Research indicates that men treated with proton therapy experience high rates of tumor control and survival. Specifically, five years after receiving proton therapy, 99% of men with early- and intermediate-risk prostate cancer remain cancer-free. Proton therapy also shows low rates of serious side effects in the urinary and digestive systems. These findings suggest that proton therapy might be a promising option for treating prostate cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

William Barrett, MD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

Men over 18 with low (T1c-T2a, Gleason 6, PSA <10) or intermediate risk (T1c-T2c, Gleason 7 and/or PSA 10-20) prostate cancer can join. They must be able to consent and have a life expectancy of more than 10 years. Those with high-risk cancer, prior treatments like prostatectomy or brachytherapy, other cancers except non-melanoma skin cancer, or under hormone therapy cannot participate.

Inclusion Criteria

My prostate cancer is classified as low or intermediate risk.

I have low risk prostate cancer.

I am able to understand and sign the consent form by myself.

Exclusion Criteria

I am unable to sign the consent form by myself due to physical or mental reasons.

I am under 18 years old.

I have had cancer before, but not skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Photon Radiation Therapy

Participants receive a course of photon intensity modulated radiation therapy (IMRT)

6-8 weeks

Proton Boost Therapy

Participants receive a boost course of proton radiation following photon therapy

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Proton Boost

Trial Overview The trial is testing if using proton radiation as an additional treatment after photon IMRT reduces side effects in treating prostate cancer compared to just photon IMRT. It also looks at how long patients stay disease-free and their overall survival after this combined treatment.

How Is the Trial Designed?

Group I: Prospective Treatment Group Experimental Treatment 1 Intervention

Proton Boost

Group II: Retrospective Comparison Group Active Control 1 Intervention

Retrospective patients previously treated with standard of care photon therapy. There is no patient interaction with this group. Data collection from medical records only.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

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]

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]

Proton therapy has been used for decades in treating prostate cancer, and advancements like pencil-beam scanning have improved its application, but the clinical benefits compared to traditional treatments are still unclear.

A randomized trial is underway to compare proton beam therapy with intensity-modulated radiotherapy for early-stage prostate cancer, which will help clarify the effectiveness and role of proton therapy in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical controversies: proton therapy for prostate cancer. Mouw, KW., Trofimov, A., Zietman, AL., et al.[2021]

In a study of 272 patients with locally advanced prostate cancer, proton-photon radiation therapy significantly reduced the incidence of acute gastrointestinal toxicity compared to conventional photon therapy, with 54.4% experiencing toxicity versus 69.2% in the control group.

While the proton-photon therapy did not reduce genitourinary toxicity or improve overall survival rates compared to standard photon therapy, it was effective in minimizing late gastrointestinal damage, with only 10.2% of patients experiencing severe late effects compared to 34.8% in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Options of hypofractionation of proton boost in locally advanced prostate cancer]. Khmelevskiĭ, EV., Pan'shin, GA., Kancheli, IN., et al.[2018]

Proton radiation therapy is gaining popularity for localized prostate cancer due to its ability to deliver high doses to the tumor while minimizing damage to surrounding healthy tissue, thanks to the unique Bragg peak effect.

While proton therapy has shown effectiveness in dose escalation for prostate cancer, it currently lacks clear dosimetric superiority over traditional X-ray intensity-modulated radiation therapy, although advancements in techniques like pencil-beam scanning may enhance its benefits in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton radiation for localized prostate cancer. Coen, JJ., Zietman, AL.[2021]

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 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]

The combination of hypofractionated proton boost therapy (20 Gy) followed by external beam radiotherapy (50 Gy) resulted in excellent 5-year PSA progression-free survival rates of 100% for low-risk, 95% for intermediate-risk, and 74% for high-risk prostate cancer patients, indicating strong efficacy in treating localized prostate cancer.

The treatment was associated with acceptable levels of genitourinary and gastrointestinal toxicities, with a decline in these side effects over time, suggesting that while bladder toxicities may be dose-limiting, the overall safety profile is favorable, especially with a median follow-up of 57 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated proton boost combined with external beam radiotherapy for treatment of localized prostate cancer. Johansson, S., Aström, L., Sandin, F., et al.[2022]

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/PMC8978248/

Proton therapy for prostate cancer: current state and future ... Proton therapy (PT) can precisely target tumors, thus sparing normal tissues and reducing side-effects without sacrificing cancer control.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405630824000995

Proton therapy toxicity outcomes for localized prostate cancer Proton therapy is associated with low rates of late high grade genitourinary and gastrointensity toxicity for the treatment of localized prostate cancer.

4. cancerletter.com cancerletter.com/clinical/20140227_6/

Five Years after Proton Therapy, 75-99% of Men Live ... Five years after having proton therapy for early- and intermediate-risk prostate cancer, 99 percent of men are living cancer-free and with excellent quality ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9009454/

Long-term Clinical Outcomes in Favorable Risk Prostate ... Long-term data regarding the disease control outcomes of proton beam therapy (PBT) for patients with favorable risk intact prostate cancer (PC) are limited.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1538472125000017

Safety and early outcomes of proton therapy and low-dose ... At 45 months' follow-up time, treatment with PT and LDR boost led to high control rates and low toxicity for men with prostate cancer.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36946610/

Proton therapy for high-risk prostate cancer: Results from ... Our results suggest early outcomes using proton therapy for HRPC are encouraging for both safety and efficacy.

8. 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) ...

9. zerocancer.org zerocancer.org/blog/5-fraction-sbrt-proton-therapy-prostate-cancer

5-Fraction SBRT Proton Therapy for Prostate Cancer Proton therapy's precision plays a vital role in reducing excess radiation to nearby normal tissues and organs, enhancing the safety and ...

10. 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- ...