Stage III Prostate Cancer AJCC v8 study: High-Dose Rate Brachytherapy vs Quality-of-Life Assessment
Official title Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer
ClinicalTrials.gov ID: NCT04725903
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Zubrod performance status 0-2
You likely can't join if
- 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...
See the full eligibility 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)...
- 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
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.