Short-Course Proton Radiation for Prostate Cancer

Recruiting at 6 trial locations

Overseen By Matthew Morocco, BS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Proton Collaborative Group

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1-9 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot continue anticoagulation medications like warfarin or heparin during the study unless they can be paused for certain procedures.

What data supports the effectiveness of the treatment Proton Radiation Hypofractionation and Proton Radiation Standard Fractionation for prostate cancer?

Research shows that hypofractionated proton therapy, which uses fewer but higher doses of radiation, is effective for prostate cancer, with studies indicating it is as effective as traditional methods and does not increase long-term side effects. Additionally, five-year outcomes from trials suggest that this approach is promising for treating prostate cancer. ^{1 2 3 4 5}

Is short-course proton radiation for prostate cancer safe for humans?

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 compared it to conventional methods and found similar rates of short-term side effects, suggesting it is a safe option. ^{1 2 6 7 8}

How does short-course proton radiation treatment for prostate cancer differ from other treatments?

Short-course proton radiation treatment for prostate cancer uses a method called hypofractionation, which involves giving higher doses of radiation over fewer sessions. This approach is more convenient and cost-effective compared to traditional longer courses, and it uses proton therapy, which can better target the cancer while sparing surrounding healthy tissue. ^{4 9 10 11 12}

Research Team

Carlos Vargas, MD

Principal Investigator

Proton Collaborative Group

Eligibility Criteria

Men over 18 with low-risk prostate cancer, confirmed within the last year, can join. They should be in good physical shape (able to walk and care for themselves), have a Gleason score of 2-6, PSA under 10 ng/ml, and no history of certain prostate treatments or pelvic radiation. No major health issues that could affect participation are allowed.

Inclusion Criteria

My prostate cancer was confirmed by a lab test within the last year.

My pelvic lymph nodes are not enlarged over 1.5 cm, or if they are, they've been tested and are not cancerous.

My PSA level was below 10 ng/ml within the last 3 months.

Exclusion Criteria

I have active inflammation or infection in my rectum due to diverticulitis, Crohn's disease, or ulcerative colitis.

I am currently on blood thinners that can be paused for treatment if necessary.

I have received chemotherapy for prostate cancer before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard-fractionation (44 treatments over 8½-9 weeks) or hypo-fractionation (5 treatments over 1-2 weeks) with proton radiation therapy

1-9 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on 2-year freedom from failure (FFF) and other outcomes

5 years

Treatment Details

Interventions

• Proton Radiation Hypofractionation
• Proton Radiation Standard Fractionation

Trial Overview This study tests two ways of giving proton radiation therapy for prostate cancer: the standard way with 44 treatments over about 9 weeks versus a higher daily dose given in just 5 treatments over one to two weeks. The goal is to see if the shorter treatment works as well or better.

Participant Groups

Group I: Proton Radiation Hypofractionation Experimental Treatment 1 Intervention

5 fractions (7.6 Gy(RBE) x 5)

Group II: Proton Radiation Standard Fractionation Active Control 1 Intervention

44 fractions (1.8 Gy(RBE) x 44)

Who Is Running the Clinical Trial?

Proton Collaborative Group

Lead Sponsor

Trials

10

Recruited

41,100+

Findings from Research

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]

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]

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 82 low-risk prostate cancer patients, those treated with hypofractionated proton-beam therapy (38 Gy in 5 treatments) and standard fractionation (79.2 Gy in 44 treatments) showed similar quality of life and urinary, bowel, and sexual function scores over 24 months.

Both treatment groups experienced excellent tolerance with no severe adverse events (grade 3 or higher), indicating that proton therapy is a safe option for prostate cancer treatment with comparable efficacy between the two fractionation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Versus Standard Fractionated Proton-beam Therapy for Low-risk Prostate Cancer: Interim Results of a Randomized Trial PCG GU 002. Vargas, CE., Hartsell, WF., Dunn, M., et al.[2019]

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]

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 ≥3) acute toxicities were reported, indicating that HFPT is a promising option for patients with localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity of image-guided hypofractionated proton therapy for localized prostate cancer. Nakajima, K., Iwata, H., Ogino, H., et al.[2018]

References

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

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

2. 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]

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

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

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

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

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. England pubmed.ncbi.nlm.nih.gov

Hypofractionated versus conventionally fractionated radiotherapy for patients with prostate cancer (HYPRO): acute toxicity results from a randomised non-inferiority phase 3 trial. [2022]

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

Hypofractionated Versus Standard Fractionated Proton-beam Therapy for Low-risk Prostate Cancer: Interim Results of a Randomized Trial PCG GU 002. [2019]

9. Australia pubmed.ncbi.nlm.nih.gov

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

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

Increasing Use of Shorter-Course Radiotherapy for Prostate Cancer. [2023]

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

Acute toxicity after hypofractionated conformal radiotherapy for localized prostate cancer: nonrandomized contemporary comparison with standard fractionation. [2018]

12. Japan pubmed.ncbi.nlm.nih.gov

Acute toxicity of image-guided hypofractionated proton therapy for localized prostate cancer. [2018]