Hypofractionated Proton Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by J. Ben Wilkinson, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Provision Center for Proton Therapy

Must not be taking: Chemotherapy

Disqualifiers: AIDS, Distant metastases, others

No Placebo Group

Approved in 3 Jurisdictions

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.

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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.

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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.

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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

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.

Trial 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

Participant Groups

The 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.

Group I: Low Risk Prostate Cancer Active Control 1 Intervention

Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks

Group II: Intermediate Risk Prostate Cancer Active Control 1 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:

🇺🇸 Approved in United States as Proton Therapy for:

• Prostate cancer
• Brain tumors
• Spinal cord tumors
• Head and neck cancers
• Retroperitoneal sarcomas

🇪🇺 Approved in European Union as Proton Therapy for:

• Prostate cancer
• Brain tumors
• Spinal cord tumors
• Head and neck cancers
• Eye tumors

🇯🇵 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

Research Locations Nearby Select from list below to view details:

Provision Cares Proton Therapy Center Nashville Nashville, TN

Provision Cares Proton Therapy Center Knoxville Knoxville, TN

Who Is Running the Clinical Trial?

Provision Center for Proton Therapy Lead Sponsor

Center for Biomedical Research, LLC Collaborator

References

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

Five-year outcomes from a prospective trial of image-guided accelerated hypofractionated proton therapy for prostate cancer. [2018] To report 5-year outcomes of a prospective trial of image-guided accelerated hypofractionated proton therapy (AHPT) for prostate cancer.

2. Japan pubmed.ncbi.nlm.nih.gov

Acute toxicity of image-guided hypofractionated proton therapy for localized prostate cancer. [2018] Hypofractionated proton therapy (HFPT) is expected to become an effective treatment approach for localized prostate cancer (PCa). The purpose of this study was to evaluate differences in acute toxicity among patients with localized PCa treated with either conventional fractionated proton therapy (CFPT) or HFPT.

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] For patients with treatment-naïve carcinoma of the prostate, hypofractionated irradiation becomes more and more popular. Due to the low α/β value of prostate cancer, increased single dose leading to a shortened treatment period seems to be safe and feasible. However, reliable data is lacking for post-prostatectomy patients so far. Further, the role of proton therapy is still under debate. Two prospective phase II trials with both, hypofractionated photon and proton therapy, provided promising results.

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

A phase II study of hypofractionated proton therapy for prostate cancer. [2022] Hypofractionated radiotherapy potentially offers therapeutic gain for prostate cancer. We investigated the feasibility of hypofractionated proton therapy (PT).

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

Four-Year Outcomes From a Prospective Phase II Clinical Trial of Moderately Hypofractionated Proton Therapy for Localized Prostate Cancer. [2020] Moderately hypofractionated radiation therapy represents an effective treatment for localized prostate cancer (PC). Although large randomized trials have reported the efficacy of photon-based hypofractionated therapy, hypofractionated proton therapy (HFPT) has not been extensively studied. This study was performed to determine the clinical and patient-reported outcomes for patients with PC treated with HFPT.

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

A Pooled Toxicity Analysis of Moderately Hypofractionated Proton Beam Therapy and Intensity Modulated Radiation Therapy in Early-Stage Prostate Cancer Patients. [2022] Data comparing moderately hypofractionated intensity modulated radiation therapy (IMRT) and proton beam therapy (PBT) are lacking. We aim to compare late toxicity profiles of patients with early-stage prostate cancer treated with moderately hypofractionated PBT and IMRT.

7. 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] To confirm the feasibility of hypofractionated proton beam therapy (PBT), we compared the acute adverse event rates and International Prostate Symptom Score (IPSS) in prostate cancer patients treated with hypofractionated versus conventionally fractionated (2.0 Gy relative biological effectiveness (RBE)/fraction) PBT.

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] Extreme hypofractionated radiotherapy for prostate cancer is a common modality in photon therapy. Pencil beam scanning (PBS) in similar fractionation allows better dose distribution and makes proton therapy more available for such patients. The purpose of this study is the feasibility of extreme proton hypofractionated radiotherapy and publication of early clinical results.