235 Participants Needed

Hypofractionated Proton Therapy for Prostate Cancer

Recruiting at 1 trial location
NE
BJ
Overseen ByBrenda J Whitehead, CCRP
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Provision Center for Proton Therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study is being proposed to evaluate the use of moderate hypofractionated proton therapy in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as gastrointestinal and genitourinary early and late toxicities will be analyzed and compared to conventional proton therapy regimens. It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.

Do I need to stop my current medications to join the trial?

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 data supports the effectiveness of the treatment Hypofractionated Proton Therapy for Prostate Cancer?

Research shows that hypofractionated proton therapy, which uses higher doses of radiation over fewer sessions, is effective for treating localized prostate cancer. Studies have reported positive outcomes and patient satisfaction, indicating it could be a promising treatment option.12345

Is hypofractionated proton therapy safe for humans?

Research shows that hypofractionated proton therapy for prostate cancer is generally safe, with studies reporting manageable side effects and promising safety profiles compared to conventional treatments.34567

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

Hypofractionated proton therapy for prostate cancer is unique because it uses proton beams instead of traditional photon beams, allowing for a more precise delivery of higher radiation doses over a shorter period, potentially reducing treatment time and side effects.13458

Research Team

JB

J. Ben Wilkinson, M.D.

Principal Investigator

Provision Center for Proton Therapy

Eligibility Criteria

Men over 18 with low or intermediate risk prostate cancer, PSA <20 ng/mL, ECOG status 0-1, no evidence of distant metastases or regional lymph node involvement. Eligible patients must have a Gleason Score <7 and clinical stage T1-T2c. Prior systemic therapy for prostate cancer disqualifies participation.

Inclusion Criteria

I have had a physical exam to determine the stage of my prostate cancer.
I was diagnosed with prostate cancer in the last year.
Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis
See 16 more

Exclusion Criteria

I have received chemotherapy for prostate cancer.
My cancer has spread to distant parts of my body.
I have had treatments like surgery, cryotherapy, or hyperthermia for prostate cancer.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hypofractionated proton therapy, 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks

4 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life outcomes after treatment

5 years
Every 6 months

Treatment Details

Interventions

  • Hypofractionated Proton Therapy
Trial OverviewThe trial is testing moderate hypofractionated proton therapy against conventional regimens in treating low and intermediate risk prostate cancer. It aims to compare quality of life outcomes and early/late gastrointestinal/genitourinary toxicities.
Participant Groups
2Treatment groups
Active Control
Group I: Low Risk Prostate CancerActive Control1 Intervention
Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
Group II: Intermediate Risk Prostate CancerActive Control1 Intervention
Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks

Hypofractionated Proton Therapy is already approved in United States, European Union, Japan for the following indications:

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Approved in United States as Proton Therapy for:
  • Prostate cancer
  • Brain tumors
  • Spinal cord tumors
  • Head and neck cancers
  • Retroperitoneal sarcomas
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Approved in European Union as Proton Therapy for:
  • Prostate cancer
  • Brain tumors
  • Spinal cord tumors
  • Head and neck cancers
  • Eye tumors
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Approved in Japan as Proton Therapy for:
  • Prostate cancer
  • Brain tumors
  • Spinal cord tumors
  • Head and neck cancers
  • Pediatric cancers

Find a Clinic Near You

Who Is Running the Clinical Trial?

Provision Center for Proton Therapy

Lead Sponsor

Trials
3
Recruited
990+

Center for Biomedical Research, LLC

Collaborator

Trials
2
Recruited
540+

Findings from Research

In a study of 526 patients with localized prostate cancer, hypofractionated proton therapy (HFPT) showed significantly lower rates of acute genitourinary toxicity compared to conventional fractionated proton therapy (CFPT), with grade 2 toxicity rates of 5.9% for HFPT versus 15% for CFPT.
Both treatment methods were safe, as no severe (grade β‰₯3) acute toxicities were reported, indicating that HFPT is a promising option for patients with localized prostate cancer.
Acute toxicity of image-guided hypofractionated proton therapy for localized prostate cancer.Nakajima, K., Iwata, H., Ogino, H., et al.[2018]
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.
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]
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]

References

Acute toxicity of image-guided hypofractionated proton therapy for localized prostate cancer. [2018]
Five-year outcomes from a prospective trial of image-guided accelerated hypofractionated proton therapy for prostate cancer. [2018]
Prostate bed irradiation with alternative radio-oncological approaches (PAROS) - a prospective, multicenter and randomized phase III trial. [2020]
A phase II study of hypofractionated proton therapy for prostate cancer. [2022]
Four-Year Outcomes From a Prospective Phase II Clinical Trial of Moderately Hypofractionated Proton Therapy for Localized Prostate Cancer. [2020]
A Pooled Toxicity Analysis of Moderately Hypofractionated Proton Beam Therapy and Intensity Modulated Radiation Therapy in Early-Stage Prostate Cancer Patients. [2022]
Acute toxicity and patient-reported symptom score after conventional versus moderately hypofractionated proton therapy for prostate cancer. [2022]
Extreme hypofractionated proton radiotherapy for prostate cancer using pencil beam scanning: Dosimetry, acute toxicity and preliminary results. [2020]