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

Trial Summary

What is the purpose of this trial?

This is a phase II study of ultrahypofractionated whole pelvis proton therapy with brachytherapy boost for patients with high risk or unfavorable intermediate risk prostate with elevated risk of lymph node involvement.

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 data supports the effectiveness of the treatment Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost for prostate cancer?

Research shows that hypofractionated proton therapy, which involves giving higher doses of radiation over fewer sessions, is effective for prostate cancer, with studies reporting positive outcomes over 5 to 7 years. Additionally, combining whole-pelvis irradiation with a targeted boost can increase the treatment's effectiveness without adding significant side effects. ^{1 2 3 4 5}

Is proton therapy with brachytherapy boost safe for prostate cancer patients?

Research shows that hypofractionated proton therapy, which is similar to the treatment you're considering, has been studied for prostate cancer and is generally safe. Studies report on the feasibility and safety of this approach, with manageable side effects and patient-reported symptoms. ^{1 2 3 5 6}

What makes the treatment of Hypofractionated Whole Pelvis Proton Therapy with Brachytherapy Boost unique for prostate cancer?

This treatment is unique because it combines hypofractionated proton therapy, which delivers higher doses of radiation in fewer sessions, with brachytherapy, a type of internal radiation, to target prostate cancer more effectively while potentially reducing side effects compared to traditional methods. ^{1 2 3 5 7}

Research Team

Arun Goel, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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 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]

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. England 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. [2018]

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

Five- and seven-year outcomes for image-guided moderately accelerated hypofractionated proton therapy for prostate cancer. [2022]

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

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