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RecruitingPhase 3

Radiation Therapy With RapidPlan Knowledge-based Planning vs Human-Driven Planning for Treatment of Prostate Cancer

Randomized Phase III Trial of Rapid-Plan Knowledge-Based Planning vs. Human-Driven Planning for Prostate Cancer Radiotherapy

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

  • Procedures mentioned: X-rays, Blood draws, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors."
  • "Additionally, patients undergo magnetic resonance imaging (MRI) pre-treatment and blood sample collection and positron emission tomography (PET) throughout study."
  • "Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study."
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 compares two ways to plan radiation treatment for prostate cancer: an automatic tool called RapidPlan and planning by a trained person. It tests whether RapidPlan leads to the same or fewer side effects. It is for adults who plan to get radiation to the prostate or the area where it was removed.

This phase III trial compares the effects of radiation therapy using RapidPlan, trademark, knowledge-based planning to human-driven planning in treating patients with prostate cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Successful delivery of radiation requires planning to develop a treatment plan for how and where the radiation is to be delivered. RapidPlan is a knowledge-based treatment planning tool that automatically creates an optimal treatment plan based on identified targets and organs at risk for radiation exposure. Human-driven treatment planning by a dosimetrist, the current standard of care, requires significant resources and time and may vary within and among radiation centers. Giving radiation therapy with RapidPlan knowledge-based planning may have similar or less side effects compared to human-driven planning in treating patients with prostate cancer.

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

Eligibility

Who can join

  • You must be at least 18 years old.
  • A tissue test must show that you have prostate cancer.
  • Your cancer stage must be T1c–T3b, Nx or N0–1, and M0–1. Your study doctor can check these stage codes.
  • You must plan to get a full treatment dose of radiation to the prostate or the area where it was removed.
  • You must be able to care for yourself and be out of bed or a chair for more than half the day (ECOG score 0–2), checked within 90 days before joining.
  • You must sign the study consent form.
  • You must finish all required tests before joining, within the required time limits.
  • You must be able to start radiation within 180 days after signing up.

Who can't join

  • You have had more than 5 Gy of radiation to the pelvis, the lower belly area. Gy is a unit of radiation dose.
  • You plan to get radiation to lymph nodes in the pelvis.
  • You plan to get brachytherapy, which places radiation sources inside the prostate.
  • You have active rectal diverticulitis, Crohn’s disease affecting the rectum, or ulcerative colitis. These conditions cause swelling in the bowel. Inactive diverticulitis and Crohn’s disease outside the rectum are allowed.
  • You have had a hip replacement or a penile implant.
  • You have a serious medical condition, addiction, or mental illness that the study doctor believes would prevent consent, treatment, or follow-up. A legal representative cannot give consent for you.
  • You use a tube to drain urine, either all the time or from time to time.

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

Official eligibility criteria

Inclusion Criteria: * Patients must be at least 18 years old * Histologically confirmed prostate cancer * Clinical or pathologic stages T1c-T3b, Nx or N0-1, M0-1 (American Joint Committee on Cancer \[AJCC\] criteria 8th edition \[Ed\]) * Planned definitive dose radiotherapy to the prostate or prostate bed * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment * Patients must sign Institutional Review Board (IRB) approved study specific informed consent * Patients must complete all required pre-entry tests within the specified time frames * Patients must be able to start treatment (radiation) within 180 days of study registration * In case of confusion about the eligibility or ineligibility of an individual patient, the principal investigator (PI) can be used as the arbiter and a note to file will be added to the subject's regulatory binder to document outcome Exclusion Criteria: * Previous pelvic radiation \> 5 Gy * Planned delivery of radiotherapy to pelvic lymph nodes * Planned delivery of brachytherapy of the prostate * Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed) * Prior hip replacement or penile implant * Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (consent by legal authorized representative is not permitted for this study) * Indwelling or intermittent urinary catheter use

Study sites (2)

AZ

FL