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Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer

Extended-Field Lymph Node Proton Irradiation for High Risk Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests proton radiation aimed at the prostate tumor and lymph nodes in the pelvis and belly. It is for people getting radiation for high-risk prostate cancer or prostate cancer that has spread to nearby lymph nodes. The study checks how well treatment works and whether it causes fewer bowel and urinary side effects.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate cancer confirmed by a tissue test and at least one high-risk feature: a Gleason score of 8 or higher (a cancer grade); spread to the sacs that make semen or nearby tissues; PSA above 20, or above 10 if taking finasteride; or cancer in certain nearby lymph nodes.
  • Be able to care for yourself and be out of bed for at least half the day, even if you cannot work.
  • Have a complete blood count, including types of white blood cells, within 90 days before joining.
  • Have at least 1,500 neutrophils per mm³. These are white blood cells that fight infection.
  • Have at least 100,000 platelets per mm³. These help blood clot.
  • Have hemoglobin of at least 8.0 g/dL. This blood protein carries oxygen. Blood transfusions or other treatment to reach this level are allowed.
  • Be able to understand the study and give consent to take part.

Who can't join

  • The listing says having no cancer spread to bones on scans before treatment is an exclusion. Ask the study team to confirm this wording.
  • The listing says having no cancer spread to distant lymph nodes on CT or MRI before treatment is an exclusion. Ask the study team to confirm this wording.
  • Have had surgery to remove the prostate or freezing treatment for prostate cancer.
  • Have had radiation, including implanted radiation seeds, that would overlap the study treatment area.
  • Have an uncontrolled illness or other problem that would limit following study requirements. Examples include bowel inflammation, HIV, an active infection, heart failure with symptoms, unstable chest pain, an abnormal heartbeat, mental illness, or difficult social circumstances.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

GA