Proton radiation therapy for high-risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of proton radiation therapy for treating patients with high-risk prostate cancer, specifically targeting the prostate tumor and surrounding lymph nodes. The approach aims to minimize gastrointestinal and genitourinary side effects compared to traditional photon radiation treatments. Patients will receive daily proton beam therapy and may also undergo a high-dose rate brachytherapy boost. Follow-up assessments will be conducted at various intervals to evaluate patient-reported outcomes and toxicity rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pathologically confirmed high-risk prostate cancer fulfilling any one of the following criteria:

  * Gleason grade 8 or higher
  * cT3b (seminal vesicle involvement) or cT4
  * Prostate specific antigen \[PSA\] \> 20 (or PSA \>10 if on finasteride)
  * Clinically or pathologically positive regional lymph nodes within the inguinal, external iliac, internal iliac, obturator, peri-rectal, pre-sacral, common iliac, or lower para-oaortc (inferior to the L2-L3 interspace) basins
* Zubrod performance status 0-2
* Complete blood cell (CBC)/differential obtained within 90 days prior to registration on study
* Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3
* Platelets \>= 100,000 cells/mm\^3
* Hemoglobin \>= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable)
* Patient must be able to provide study specific informed consent

Exclusion Criteria:

* Absence of bone metastasis by bone scan or metabolic imaging (e.g. NaF PET, FACBC PET, PSMA PET, etc.) before the start of therapy.
* Absence of distant lymph node metastasis by CT and/or MRI before the start of therapy.
* Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
* Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
* Uncontrolled intercurrent illness including, but not limited to, inflammatory bowel disease, human immunodeficiency virus infection, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Where it's running

• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Pretesh R Patel — Emory University Hospital/Winship Cancer Institute
• Study coordinator: Pretesh Patel, MD
• Email: pretesh.patel@emory.edu
• Phone: 404-778-3473

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Androgen therapy with or without niraparib for high-risk prostate cancer after radiation

  This study is testing whether adding the drug niraparib to hormone therapy after radiation can help men with high-risk prostate cancer do better than hormone therapy alone.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT04947254

• Combining high dose-rate brachytherapy and stereotactic body radiotherapy for prostate cancer treatment

  This study is testing whether combining two types of radiation therapy can improve treatment outcomes for men with prostate cancer.

  Recruiting Jonsson Comprehensive Cancer Center · Los Angeles, California · NCT04945642

• Focal ablation treatments for localized prostate cancer

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  Recruiting University of California, Davis · Sacramento, California · NCT06178354

• Hormone therapy and targeted radiation for prostate cancer treatment

  This study is testing if combining a hormone therapy that blocks testosterone with targeted radiation can help men with prostate cancer see better results and improve their quality of life.

  Recruiting Phase 2 Jonsson Comprehensive Cancer Center · Los Angeles, California · NCT06067269

• Carboplatin treatment before surgery for high-risk prostate cancer with BRCA mutations

  This study is testing if giving carboplatin chemotherapy before surgery can help men with high-risk prostate cancer and BRCA mutations have better outcomes.

  Recruiting at 132 sites Phase 2 SWOG Cancer Research Network · Anchorage, Alaska and 132 other locations · NCT05806515

• Peer genetic coaching for African American men with metastatic prostate cancer

  This study tests whether having trained peer coaches can help African American men with metastatic prostate cancer understand and access genetic testing better.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT05627219

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.