NCT04725903 Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer
| NCT ID | NCT04725903 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Stage III Prostate Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2021-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase II trial investigates whether proton radiation therapy directed to the prostate tumor, pelvic, and para-aortic lymph nodes, is an effective way to treat patients with high-risk or lymph node positive 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.
Eligibility Criteria
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
Contact & Investigator
Pretesh R Patel
PRINCIPAL INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Frequently Asked Questions
Who can join the NCT04725903 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Stage III Prostate Cancer AJCC v8. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04725903 currently recruiting?
Yes, NCT04725903 is actively recruiting participants. Contact the research team at pretesh.patel@emory.edu for enrollment information.
Where is the NCT04725903 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT04725903 clinical trial?
NCT04725903 is sponsored by Emory University. The principal investigator is Pretesh R Patel at Emory University Hospital/Winship Cancer Institute. The trial plans to enroll 30 participants.
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