Proton Therapy and Brachytherapy for Prostate Cancer

Overseen By Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Abramson Cancer Center at Penn Medicine

Must be taking: Androgen deprivation

Must not be taking: Therapeutic anticoagulation

Disqualifiers: Metastatic disease, Prior radiation, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat prostate cancer that is high risk or may spread to nearby lymph nodes. Researchers aim to determine if combining two radiation treatments, delivered in fewer sessions with a higher dose each time, is safe and effective. This method, called Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost, combines proton therapy and brachytherapy. The trial seeks participants diagnosed with high or intermediate-risk prostate cancer, who have not received prior radiation in the pelvic area, and do not have certain health conditions like inflammatory bowel disease. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in prostate cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you should not be on therapeutic anticoagulation (blood thinners). It's best to discuss your current medications with the trial team to see if any adjustments are needed.

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

Research has shown that hypofractionated whole pelvis proton therapy with brachytherapy, a type of prostate cancer treatment, is generally well-tolerated. In some studies, most patients reported only mild side effects. Approximately 91% of patients received brachytherapy, a form of radiation placed inside the body, as part of this treatment.

Some patients experienced side effects affecting the stomach, intestines, bladder, and urinary tract. These side effects were mostly mild to moderate, meaning they were noticeable but not severe.

Overall, while side effects can occur, they are usually manageable. This treatment is currently in a phase that evaluates both safety and effectiveness, indicating it has already passed basic safety checks. ^{1 2 3 4 5}

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

Researchers are excited about using hypofractionated whole pelvis proton therapy with a brachytherapy boost for prostate cancer because it offers a potentially more efficient and targeted approach. Unlike the standard treatment, which involves brachytherapy followed by 25 sessions of radiation therapy, this method condenses the treatment into just 5 sessions, each with a higher dose. This not only aims to improve the precision of targeting cancer cells but also reduces the overall treatment time, which could enhance patient convenience and quality of life.

What evidence suggests that hypofractionated whole pelvis proton therapy with brachytherapy boost might be an effective treatment for prostate cancer?

This trial will evaluate the safety and effectiveness of using proton therapy with a brachytherapy boost for treating high-risk prostate cancer. Research has shown that a shorter, more intense form of radiotherapy, combined with a brachytherapy boost, can be safe and effective. Studies have found that this approach has manageable side effects related to urinary and bowel functions, common concerns in prostate cancer treatments. Additionally, ongoing research compares this method to other treatments, highlighting its potential benefits. This suggests that the treatment could effectively target prostate cancer while minimally impacting patients' quality of life. ^{1 2 3 6 7}

Who Is on the Research Team?

Arun Goel, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults with high risk or unfavorable intermediate risk prostate cancer, who haven't had pelvic radiation before. They must be able to undergo a rectal spacer procedure and have no history of certain diseases like inflammatory bowel disease. Patients may have started hormone therapy but not had prior treatments that would exclude them.

Inclusion Criteria

My prostate cancer has been confirmed by a biopsy.

My prostate cancer is classified as high or intermediate risk.

I've had a recent check-up, MRI, PSMA PET scan, and PSA test for prostate cancer.

Exclusion Criteria

I have had radiation treatment to my pelvic area.

I have been cancer-free for at least 5 years, except for non-melanoma skin cancers.

I have never had a prostate surgery known as TURP.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brachytherapy boost followed by whole pelvis proton radiation therapy in 5 fractions

5 weeks

5 visits (in-person)

Follow-up

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

First year of treatment

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost

Trial Overview The study tests ultrahypofractionated whole pelvis proton therapy combined with a brachytherapy boost in patients with prostate cancer at high risk of lymph node involvement. It's a phase II trial to see how well patients tolerate this treatment and its effectiveness.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

The standard treatment for patients with prostate cancer is to receive brachytherapy boost and then radiation therapy in 25 fractions. This research study is being conducted to see how safe and effective delivering brachytherapy boost and then whole pelvis proton radiation therapy in 5 fractions (with each fraction having a higher dose than each fraction in the standard treatment) is in treating patients with prostate cancer. Subjects will also be asked to complete quality of life questionnaires for this study.

Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost is already approved in United States, European Union for the following indications:

Approved in United States as Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost for:

• High-risk prostate cancer
• Unfavorable intermediate-risk prostate cancer with elevated risk of lymph node involvement

Approved in European Union as Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost for:

• High-risk prostate cancer
• Locally advanced prostate cancer

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Published Research Related to This Trial

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 41 patients with high-risk localized prostate cancer, combining whole-pelvis irradiation with a stereotactic body radiotherapy (SBRT) boost resulted in a high 4-year biochemical failure-free survival rate of 91.9%, indicating effective cancer control.

The treatment was associated with minimal toxicity, with no severe (grade 3) gastrointestinal or genitourinary side effects reported, suggesting that this approach is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. Lin, YW., Lin, LC., Lin, KL.[2020]

In a study of 582 prostate cancer patients treated with moderately accelerated hypofractionated proton therapy (AHPT), the 5- and 7-year rates of freedom from biochemical progression were very high, at 96.8% and 95.2% overall, indicating strong long-term efficacy of this treatment.

The treatment was associated with minimal toxicities, with low rates of grade 2 gastrointestinal (9.9% at 5 years) and grade 3 genitourinary (1.3% at 5 years) side effects, and no severe toxicities (grade ≥4) reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five- and seven-year outcomes for image-guided moderately accelerated hypofractionated proton therapy for prostate cancer. Henderson, RH., Bryant, CM., Nichols, RC., et al.[2022]

In a study of 78 high-risk prostate cancer patients, treatment with normofractionated whole pelvic radiotherapy followed by a hypofractionated boost using intensity-modulated radiotherapy (IMRT) showed excellent tolerance, with only 1% experiencing severe acute toxicity and no patients reporting grade 4 toxicity.

With a median follow-up of 57 months, the treatment resulted in high rates of disease control, including an 84.5% biochemical disease-free survival rate, indicating that this approach is effective for managing non-metastatic prostate cancer at high risk of lymph node involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated external beam radiotherapy to boost the prostate with ≥85 Gy/equivalent dose for patients with localised disease at high risk of lymph node involvement: feasibility, tolerance and outcome. Zilli, T., Jorcano, S., Escudé, L., 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.

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06591819

NCT06591819 | Hypofractionated WPPT With HDR Boost This research study is being conducted to see how safe and effective delivering brachytherapy boost and then whole pelvis proton radiation therapy in 5 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016781402505203X

Ultra-hypofractionated radiotherapy combined with HDR ... Purpose. To evaluate safety and efficacy of ultra hypofractionated radiotherapy (UHF) combined with high dose rate brachytherapy boost (HDR-BB) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8772149/

Safety of accelerated hypofractionated whole pelvis ... Accelerated, hypofractionated whole pelvis radiotherapy was associated with acceptable GU and GI toxicities and should be further validated for those at risk ...

4. vvh.org vvh.org/documents/Rossi-2025-Publication_High-Dose-Rate.HDR)-Brachytherapy-Boost.pdf

High-dose-rate (HDR) brachytherapy boost in combination ... The PIVOTALboost trial (79) is an ongoing phase 3 randomized trial for patients with intermediate and high- risk prostate cancer in the UK that is comparing ...

5. redjournal.org redjournal.org/article/S0360-3016(24)00381-X/fulltext

A Randomized Trial Comparing Quality of Life After Low ... A Randomized Trial Comparing Quality of Life After Low-Dose Rate or High-Dose Rate Prostate Brachytherapy Boost With Pelvic External Beam ...

6. profiles.wustl.edu profiles.wustl.edu/en/publications/safety-of-accelerated-hypofractionated-whole-pelvis-radiation-the/

Safety of accelerated hypofractionated whole pelvis ... Safety of accelerated hypofractionated whole pelvis radiation therapy prior to high dose rate brachytherapy or stereotactic body radiation therapy prostate ...

7. redjournal.org redjournal.org/article/S0360-3016(23)08006-9/abstract

Safety of Ultrahypofractionated Pelvic Nodal Irradiation in ... Primary outcomes included the presence of grade ≥2 rates of acute and late gastrointestinal and genitourinary toxicity based on the Common Terminology Criteria ...