Proton Radiation Therapy for the Treatment of Patients with High Risk Prostate Cancer
Prostate Cancer
Unknown Primary
RAD5131-20 (primary)
NCI-2020-07113
Summary
This phase II trial investigates whether proton radiation therapy directed to the prostate tumor and nearby lymph nodes, is an effective way to treat patients with high-risk prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and genitourinary side effects. Proton beam therapy is a new type of radiotherapy that directs multiple beams of protons (positively charged subatomic particles) at the tumor target, where they deposit the bulk of their energy with essentially no residual radiation beyond the tumor. By reducing the exposure of the healthy tissues and organs to radiation in the treatment of prostate cancer, proton therapy has the potential to better spare healthy tissue and reduce the side effects of radiation therapy. The information learned from this study may also help researchers to learn more about proton therapy for the treatment of patients with prostate cancer.
Objectives
PRIMARY OBJECTIVE:
I. To determine the rate of acute grade 2+ gastrointestinal toxicity compared to historical photon treatments.
SECONDARY OBJECTIVES:
I. To determine the rate of acute grade 2+ genitourinary toxicity compared to historical photon treatments.
II. To assess the feasibility of extended-field proton irradiation of high-risk prostate.
III. To demonstrate safety of proton therapy followed by high dose rate (HDR) boost.
IV. To determine patient-reported outcomes (PROs) of toxicity.
OUTLINE:
Patients undergo pelvic proton beam therapy daily on Monday-Friday for 7-9 weeks. Patients may receive a high-dose rate brachytherapy boost. Patients also undergo collection of blood samples at screening and during follow up, may undergo bone scan and digital rectal exam (DRE) at screening, and undergo computed tomography (CT) or magnetic resonance imaging (MRI) at screening and then as clinically indicated.
After completion of study treatment, patients are followed up at 1, 3, 6, 9 and 12 months, and 1.5, 2, 2.5, and 3 years.
Eligibility
- 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
- Age 18 or greater
- Complete blood cell (CBC)/differential obtained within 90 days prior to registration on study
- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 90 days prior to registration on study)
- Platelets >= 100,000 cells/mm^3 (obtained within 90 days prior to registration on study)
- Hemoglobin >= 8.0 g/dl (obtained within 90 days prior to registration on study) (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
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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