Short-course Proton Radiation for Prostate Cancer

(PR07 Trial)

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Saw palmetto, Methotrexate, Anticoagulants

Disqualifiers: Inflammatory bowel disease, Hip replacement, others

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

Compensation: Varies

Number of Visits: Unknown

361 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.

Will I have to stop taking my current medications?

If you are taking Saw Palmetto or methotrexate, you will need to stop using them during the radiation treatment. If you are on certain blood thinners like Warfarin, Plavix, Pradaxa, Lovenox, or Aggrenox, you cannot participate in the trial.

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

Research shows that hypofractionated proton therapy, which uses fewer but higher doses of radiation, is effective for prostate cancer, with studies reporting promising results and high efficacy. It is considered safe and feasible, with evidence suggesting it is as effective as traditional methods without added long-term side effects. ^{1 2 3 4 5}

Is short-course proton radiation therapy safe for prostate cancer patients?

Research shows that hypofractionated proton therapy, which involves giving higher doses of radiation over a shorter period, is generally safe for prostate cancer patients. Studies have found that it can reduce certain side effects, like gastrointestinal issues, compared to traditional methods, although it does not significantly change the risk of urinary tract damage. ^{1 3 4 6 7}

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

Hypofractionated proton radiation therapy for prostate cancer is unique because it uses a higher dose of radiation in fewer sessions, which can shorten the overall treatment time. This approach, using proton therapy, may offer better precision in targeting the cancer while minimizing damage to surrounding healthy tissues compared to traditional radiation methods. ^{1 3 4 5 8}

Research Team

Curtis Bryant, MD, MPH

Principal Investigator

University of Florida Proton Therapy Institute

Eligibility Criteria

Men with prostate cancer who have a PSA level of 20 ng/ml or lower and a Gleason score between 2-7 can join this trial. They shouldn't have had previous prostate cancer surgery, pelvic radiation, certain intrapelvic surgeries, systemic chemotherapy for prostate cancer, or be on specific anticoagulants like Warfarin.

Inclusion Criteria

I have prostate cancer.

My prostate cancer has a low to intermediate Gleason score.

PSA ≤ 20 ng/ml

Exclusion Criteria

I have had surgery in my pelvic area before.

I have had surgery or radiation for prostate cancer.

History of hip replacement

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive hypofractionated proton radiation therapy for prostate cancer

5.5-6 weeks

Follow-up

Participants are monitored for disease control and overall survival after treatment

Up to 20 years

Treatment Details

Interventions

• Hypofractionated Proton Radiation Therapy

Trial Overview The trial is testing two different doses of proton radiation therapy (70 Gy/CGE and 72.5 Gy/CGE) to see if a shorter treatment duration (5½-6 weeks) is as effective and has fewer side effects compared to the standard longer course (8 weeks).

Participant Groups

Group I: Low Risk Experimental Treatment 1 Intervention

70 Gy/CGE

Group II: Intermediate Risk Experimental Treatment 1 Intervention

72.5 Gy/CGE

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

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]

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]

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 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 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 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]

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]

References

1. 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]

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

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

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

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

5. 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]

6. 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]

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

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

8. Australia pubmed.ncbi.nlm.nih.gov

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