Proton SBRT for Prostate Cancer

Overseen By Ryan Holder, BS

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: The New York Proton Center

Disqualifiers: Prior prostate surgery, Chronic prostatitis, Urethral stricture, Active cancer, others

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

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

Compensation: Varies

Number of Visits: 11

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation therapy called pencil beam scanning proton SBRT for men with low- to intermediate-risk prostate cancer. The main goal is to determine if this treatment causes fewer urinary and digestive side effects compared to traditional methods. Researchers also examine how this treatment impacts patients' quality of life, including urinary, bowel, sexual, and financial outcomes. Men with a confirmed diagnosis of prostate cancer who have not undergone prostate surgery and can commit to a 2-year follow-up may be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in prostate cancer care.

Will I have to stop taking my current medications?

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 prior data suggests that this technique is safe for prostate cancer treatment?

Research has shown that pencil beam scanning proton therapy, a type of targeted radiation, is generally easy for patients to handle. Studies have found that this therapy works as well as traditional radiation but may cause fewer side effects. Patients using this method have reported fewer serious urinary or digestive problems, which are common with radiation treatments.

Previous research has demonstrated that this treatment is safe, with few reports of serious side effects. While mild side effects like tiredness or temporary urinary changes are common with radiation therapy, serious issues were rare.

This type of proton therapy has been used to treat prostate cancer with good early results. Most patients did not experience severe side effects, making it a promising option for those considering clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about Pencil Beam Scanning (PBS) Proton SBRT for prostate cancer because it offers a highly precise way to deliver radiation therapy. Unlike traditional radiation treatments that can affect surrounding healthy tissues, PBS uses a focused beam of protons to target tumors more accurately, potentially reducing side effects. Additionally, this method can deliver a higher dose of radiation in fewer sessions, which might improve patient convenience and outcomes. By minimizing damage to healthy tissues and concentrating on the tumor, PBS Proton SBRT could offer a more effective and safer alternative for prostate cancer treatment.

What evidence suggests that this treatment might be an effective treatment for prostate cancer?

Research has shown that pencil beam scanning proton therapy, a precise type of radiation treatment, might enhance prostate cancer care compared to other methods. In this trial, participants will receive stereotactic body radiation therapy (SBRT) with Pencil Beam Scanning (PBS) proton therapy. Photon-based SBRT is already effective for prostate cancer, and this new proton therapy aims to match or surpass its effectiveness while reducing side effects. Early results suggest that this targeted proton therapy could cause less harm to nearby healthy tissue, potentially leading to fewer urinary and digestive problems. Although direct comparisons between these methods are still under investigation, the precision of pencil beam scanning offers hope for better patient outcomes. ^{3 4 6 7 8}

Who Is on the Research Team?

Shaakir Hasan, DO

Principal Investigator

The New York Proton Center

Daniel Gorovets, MD

Principal Investigator

The New York Proton Center

Are You a Good Fit for This Trial?

Men over 18 with low or intermediate-risk prostate cancer, a Gleason score ≤7, PSA ≤20 ng/ml, and no prior major prostate surgery. They must have a life expectancy of more than 2 years and be able to follow up for at least that time. Participants need an IPSS score ≤20, KPS ≥80%, and agree to specific procedures like fiducial marker placement.

Inclusion Criteria

I am a man aged 18 or older.

My prostate is smaller than 100 cc, confirmed by MRI or CT scan.

IPSS ≤ 20

Exclusion Criteria

I have had chronic prostatitis or a narrowed urethra in the past.

Your doctor estimates that you have less than 2 years to live.

I don't have active cancer, except for non-serious skin cancers, and my doctor thinks I'm unlikely to relapse soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pencil beam scanning proton SBRT (40Gy RBE in 5 fractions delivered every other day)

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at 1, 3, 6, 12, 18, and 24 months

24 months

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Pencil Beam Scanning Proton SBRT

Trial Overview The trial is testing pencil beam scanning proton SBRT as a treatment for prostate cancer. It involves delivering radiation in five sessions every other day. The main goal is to see if this method causes less severe urinary or gastrointestinal side effects compared to traditional treatments after two years.

How Is the Trial Designed?

Group I: Stereotactic body radiation therapy (SBRT) with Pencil Beam Scanning (PBS) proton therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The New York Proton Center

Lead Sponsor

Trials

3

Recruited

1,900+

Published Research Related to This Trial

In a study of 33 patients with localized prostate cancer treated with modern proton beam radiotherapy (PBT), there were no severe acute toxicities, indicating a high safety profile for this treatment method.

With a median follow-up of 18 months, the use of hydrogel rectal spacers and fiducial tracking without endorectal balloons resulted in minimal treatment-related toxicity and promising oncologic outcomes, although late erectile dysfunction was noted as a common issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Cancer Treatment with Pencil Beam Proton Therapy Using Rectal Spacers sans Endorectal Balloons. Forsthoefel, M., Hankins, R., Ballew, E., et al.[2022]

In a study of 304 men with localized prostate cancer, those treated with pencil beam scanning (PBS) showed a higher proportion of significant declines in urinary quality of life (QOL) compared to those treated with passive scatter/uniform scanning (PS/US) at 12 months, indicating a potential difference in outcomes between the two proton therapy methods.

However, overall average quality-of-life declines did not significantly differ between PBS and PS/US, suggesting that while there may be specific areas of concern, both treatment modalities have similar average effects on patient-reported outcomes over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported outcomes following proton pencil beam scanning vs. passive scatter/uniform scanning for localized prostate cancer: Secondary analysis of PCG 001-09. Mishra, MV., Khairnar, R., Bentzen, SM., et al.[2022]

In a study of 23 patients with high-risk prostate cancer, stereotactic body radiation therapy (SBRT) was found to be feasible and well tolerated, with low rates of severe gastrointestinal (GI) and genitourinary (GU) toxicities.

The treatment resulted in acute grade 1 GI toxicities in only 9.1% of patients and grade 3 GU toxicities in 4.5%, indicating that serious side effects were uncommon, but further long-term follow-up is needed to assess ongoing safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Tolerance Outcomes of Stereotactic Hypofractionated Accelerated Radiation Therapy Concomitant with Pelvic Node Irradiation in High-risk Prostate Cancer. Pinitpatcharalert, A., Happersett, L., Kollmeier, M., et al.[2022]

In a study of 192 prostate cancer patients treated with proton beam therapy (PBT) over a median follow-up of 1.7 years, only 5 patients experienced grade 3 toxicity, with no occurrences of grade 4 or 5 toxicity, indicating a high safety profile for this treatment.

Patient-reported outcomes showed stable urinary function post-treatment, while sexual health scores declined slightly at 1 year but did not worsen thereafter; bowel function scores also decreased but stabilized, suggesting manageable side effects associated with PBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early toxicity and patient reported quality-of-life in patients receiving proton therapy for localized prostate cancer: a single institutional review of prospectively recorded outcomes. Lee, HJ., Macomber, MW., Spraker, MB., et al.[2019]

Stereotactic body proton therapy (SBPT) showed greater dose escalation potential compared to stereotactic body photon therapy (SBXT) in treating prostate cancer, particularly for larger prostate volumes, indicating it may be a more effective option for high-risk patients.

In a study of 25 patients, SBPT resulted in lower doses to critical structures like the bladder neck while still achieving significant target coverage, suggesting a safer treatment profile with potentially fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation of an HDR "Boost" with Stereotactic Proton versus Photon Therapy in Prostate Cancer: A Dosimetric Feasibility Study. Remick, JS., Sabouri, P., Zhu, M., et al.[2022]

Whole-pelvis pencil beam scanning (PBS) proton therapy is effective for treating prostate cancer, providing good target coverage while minimizing damage to surrounding organs at risk (OAR).

Two treatment planning approaches, conventional optimization (CO) and robust optimization (RO), were evaluated, with RO offering potential advantages in OAR sparing and efficiency, while CO remains a viable option for institutions lacking advanced capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robust treatment planning in whole pelvis pencil beam scanning proton therapy for prostate cancer. Butala, AA., Ingram, WS., O'Reilly, SE., et al.[2021]

In a study comparing proton beam therapy (PBT) techniques for prostate cancer, acute gastrointestinal toxicity rates were similar between pencil beam scanning (PBS) and passive scattering/uniform scanning (PS/US), with rates of 2.9% and 2.1% respectively.

However, PBS was associated with significantly higher acute genitourinary toxicity (21.9% vs. 15.1% for PS/US), indicating a need for further investigation into the safety profiles of these treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton beam therapy delivered using pencil beam scanning vs. passive scattering/uniform scanning for localized prostate cancer: Comparative toxicity analysis of PCG 001-09. Mishra, MV., Khairnar, R., Bentzen, SM., et al.[2022]

Citations

1. redjournal.org redjournal.org/article/S0360-3016(25)03375-9/fulltext

Early Outcomes from a Prospective Phase II Trial of Pencil ... Photon-based stereotactic body radiation therapy (SBRT) is quicker and more cost-effective, but otherwise equivalent to longer courses of prostate radiation.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301625033759

Early Outcomes from a Prospective Phase II Trial of Pencil ... Photon-based stereotactic body radiation therapy (SBRT) is quicker and more cost-effective, but otherwise equivalent to longer courses of prostate radiation.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6804653/

Proton beam therapy delivered using pencil ... Benefits of proton beam therapy for treatment of prostate cancer are unknown. Data comparing pencil beam vs. passive scatter/uniform scanning protons are ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10886728/

Potential Therapeutic Improvements in Prostate Cancer ... Simple Summary. LET-optimized pencil beam scanning (PBS) proton treatment plans have the potential to improve patient outcomes.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04842890

Phase II Study of Pencil Beam Scanning Proton ... The primary aim is to assess GU/GI toxicity of proton SBRT and compare this to historic outcomes associated with photon-based prostate SBRT. The primary ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625033759

Early Outcomes from a Prospective Phase II Trial of Pencil ... Photon-based stereotactic body radiation therapy (SBRT) is quicker and more cost-effective, but otherwise equivalent to longer courses of prostate radiation.

7. redjournal.org redjournal.org/article/S0360-3016(25)03375-9/abstract

Early Outcomes from a Prospective Phase II Trial of Pencil ... Photon-based stereotactic body radiation therapy (SBRT) is quicker and more cost-effective, but otherwise equivalent to longer courses of prostate radiation.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2331518023002275

Prostate Cancer Treatment with Pencil Beam Proton ... We report the early clinical outcomes of patients treated for localized prostate cancer using modern PBS–PBT with hydrogel rectal spacing and fiducial tracking