Short-course Proton Radiation for Prostate Cancer

(PR07 Trial)

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a shorter course of proton radiation therapy for prostate cancer, aiming to reduce treatment time while minimizing side effects on the bladder and rectum. The researchers aim to maintain the effectiveness of longer treatments in killing cancer cells. Participants should have prostate cancer with a Gleason score of 2-7 and a PSA level of 20 or less, without prior prostate surgery or inflammatory bowel disease.

As an unphased trial, it offers patients the opportunity to contribute to innovative research that could improve future treatment options.

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 prior data suggests that hypofractionated proton radiation therapy is safe for prostate cancer?

Research has shown that hypofractionated proton radiation therapy is generally safe for treating prostate cancer. One study found it safe and effective for patients with low-risk prostate cancer, using 60 Gy over 20 sessions. Another study reported fewer bladder and urinary side effects compared to traditional photon therapy. Additionally, a different study showed a high survival rate, with only one prostate cancer death over five years. This evidence suggests the treatment is well-tolerated with few serious side effects.12345

Why are researchers excited about this trial?

Researchers are excited about hypofractionated proton radiation therapy for prostate cancer because it offers a more precise and potentially faster treatment option. Unlike traditional radiation therapies, which can take several weeks, hypofractionated proton therapy delivers higher doses of radiation in fewer sessions, possibly reducing treatment time and improving patient convenience. This method uses proton beams, which can more accurately target tumors while sparing surrounding healthy tissue, potentially leading to fewer side effects. By tailoring the radiation dose to the risk level, this approach might provide a more customized treatment strategy for both low-risk and intermediate-risk prostate cancer patients.

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

Research has shown that a shorter course of proton radiation therapy effectively treats prostate cancer. One study found that 86.3% of patients who received this treatment remained cancer-free five years later, indicating that most did not experience a recurrence during that period. In this trial, participants will receive hypofractionated proton radiation therapy tailored to their risk level, with separate treatment arms for low-risk and intermediate-risk prostate cancer. Additionally, proton therapy often causes fewer urinary side effects than traditional radiation. Another study demonstrated its effectiveness for patients with both low- and intermediate-risk prostate cancer. These findings suggest that this type of proton radiation can effectively treat prostate cancer while reducing side effects.12456

Who Is on the Research Team?

CB

Curtis Bryant, MD, MPH

Principal Investigator

University of Florida Proton Therapy Institute

Are You a Good Fit for This Trial?

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.
I am taking Saw Palmetto or methotrexate and cannot or do not want to stop during radiation.
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Low RiskExperimental Treatment1 Intervention
Group II: Intermediate RiskExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Published Research Related to This Trial

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

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39672515/
Five-Year Outcomes of Moderately Hypofractionated ...This regimen of moderately hypofractionated IMPT for HR or UIR-PCa yielded encouraging 5-year RFR, DFS, and late AE outcomes.
Hypofractionated Proton Therapy in Early Prostate CancerThe 5-year disease-free survival rate in the hypofractionated arm of this study was 86.3% (95% confidence interval, 83.1–89), and the rates of late grade 3 or ...
Hypofractionated Radiotherapy for Prostate CancerProton therapy was associated with reduced GU toxicity compared to photon therapy, based on assessments from both physicians and patients.
5-Years Analysis of Effectivity and Toxicity of Ultra- ...Ultra-hypofractionated proton radiotherapy using PBS is highly effective in the treatment of low- and intermediate-risk prostate cancer. We ...
Photon vs proton hypofractionation in prostate cancerHigh-level evidence on hypofractionated proton therapy (PT) for localized and locally advanced prostate cancer (PCa) patients is currently missing.
Treatment outcomes with hypofractionated high-dose ...The 5-year overall survival rate was 92%. Only 1 patient died from the disease at 48 months after treatment, giving a 5-year cancer-specific survival of 98%.
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