Proton Therapy and Brachytherapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Arun Goel, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Prior Safety Data

Approved in 2 Jurisdictions

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pennsylvania Philadelphia, PA

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine Lead Sponsor

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] We report the outcome of hypofractionated proton boost as an alternative to high dose-rate brachytherapy boost, aimed at an equivalent dose exceeding 86 Gy in 2 Gy fractions, for patients with localized prostate cancer and all risk groups.

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

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] The rationale for hypofractionated radiotherapy in the treatment of prostate cancer is based on the modern understanding of radiobiology and advances in stereotactic body radiotherapy (SBRT) techniques. Whole-pelvis irradiation combined with SBRT boost for high-risk prostate cancer might escalate biologically effective dose without increasing toxicity. Here, we report our 4-year results of SBRT boost for high-risk localized prostate cancer.

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] To evaluate the tolerance and preliminary outcome of prostate cancer patients at high risk of lymph node involvement treated with normofractionated whole pelvic radiotherapy (WPRT) followed by a hypofractionated boost to the prostate with an intensity-modulated radiotherapy (IMRT) technique.

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

Five- and seven-year outcomes for image-guided moderately accelerated hypofractionated proton therapy for prostate cancer. [2022] To report 5- and 7-year outcomes after image-guided moderately accelerated hypofractionated proton therapy (AHPT) for prostate cancer.

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] 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.

7. 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).