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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This study uses photon radiation with a proton boost to treat prostate cancer. The purpose of this study is to determine if proton therapy as a boost following photon intensity modulated radiation therapy (IMRT) produces decreased toxicity as compared to conventional photon IMRT alone in the treatment of prostate cancer. Our secondary objective is to determine the effectiveness of this treatment regimen. Effectiveness will be determined by length of time to progression or recurrence of disease and overall survival. Patients on this study will be treated with a course of photon radiation therapy followed by a boost course of proton radiation.

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 data supports the effectiveness of the treatment Proton Boost for prostate cancer?

Research shows that using proton boost therapy for prostate cancer can increase the dose to the tumor without increasing side effects, which suggests it might be effective. Additionally, studies have shown that proton therapy can be a promising alternative to other high-dose treatments, with minimal complications observed. ^{1 2 3 4 5}

Is proton therapy safe for treating prostate cancer?

Proton therapy for prostate cancer has been studied for its safety, showing acceptable levels of treatment-related side effects. Some patients experience mild bladder and bowel issues, but these tend to improve over time. Overall, the treatment is considered safe with manageable side effects. ^{1 6 7 8 9}

How does proton therapy differ from other treatments for prostate cancer?

Proton therapy for prostate cancer is unique because it uses a proton beam that can deliver high doses of radiation directly to the tumor with minimal impact on surrounding healthy tissue, thanks to a property called the Bragg peak. This allows for precise targeting and potentially fewer side effects compared to traditional X-ray radiation therapies. ^{1 3 5 10 11}

Research Team

William Barrett, MD

Principal Investigator

University of Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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 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]

References

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

Phase II feasibility study of high-dose radiotherapy for prostate cancer using proton boost therapy: first clinical trial of proton beam therapy for prostate cancer in Japan. [2006]

2. United States 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. [2019]

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

Conformal proton therapy for early-stage prostate cancer. [2019]

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

Clinical controversies: proton therapy for prostate cancer. [2021]

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

Proton versus intensity-modulated radiotherapy for prostate cancer: patterns of care and early toxicity. [2022]

7. 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]

8. Egypt pubmed.ncbi.nlm.nih.gov

Hypofractionated proton boost combined with external beam radiotherapy for treatment of localized prostate cancer. [2022]

9. 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]

10. England pubmed.ncbi.nlm.nih.gov

Proton radiation for localized prostate cancer. [2021]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Options of hypofractionation of proton boost in locally advanced prostate cancer]. [2018]