No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Male
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Emory University · Other
Who this trial is looking for
This trial is looking for patients with high-risk prostate cancer who are receiving radiation therapy. Participants will receive proton radiation directed at the tumor and nearby lymph nodes to see if it is effective and causes fewer side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with high-risk prostate cancer
I have a Gleason grade of 8 or higher
My prostate specific antigen (PSA) is above 20
I have positive regional lymph nodes in specified areas
I have a performance status of 0-2
I have a complete blood count done within the last 90 days
My absolute neutrophil count is at least 1,500 cells/mm^3
I can give informed consent for the study
You may not be able to join if
I have no bone metastasis before starting therapy
I have no distant lymph node metastasis before starting therapy
I have had radical surgery for prostate cancer
I have had prior radiation therapy to the affected area
I have uncontrolled health issues like inflammatory bowel disease or active infections
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 d…
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.
Trial Locations
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Status
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 pathologi…
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
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