Study on Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Prostate Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT00809991

Provider View

This clinical trial is testing a new radiation therapy approach for treating localized prostate cancer. The study aims to determine if this method is as effective or more effective than the current standard treatment, while also evaluating its safety.

Patient Parameters

Program Overview

This Phase II study is exploring a specific radiation therapy method to treat localized prostate cancer. The goal is to see if this approach can effectively control the tumor with fewer side effects compared to traditional treatments. The radiation dose is based on previous studies that have shown it to be safe and effective. Researchers believe this method might work better for prostate cancer than the current standard therapy.

Description

Radiation therapy is a common treatment for prostate cancer that hasn't spread beyond the prostate. Traditionally, this involves giving small doses of radiation daily. This method is based on research showing how different tissues respond to radiation. Tumors and normal tissues react differently to radiation doses, and prostate tumors might respond more like normal tissues. This study is testing a new approach that uses higher daily doses of radiation, which might be more effective for prostate cancer.

Previous studies have shown promising results with higher doses, leading to good control of prostate-specific antigen (PSA) levels, which is a marker for prostate cancer. These studies reported good survival rates without increased side effects. However, more research is needed to confirm these findings. If the theory about prostate cancer's response to radiation is correct, using higher doses could be more beneficial. But if it's incorrect, there might be more side effects.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of prostate cancer that hasn't spread beyond the prostate.
  • Cancer stage between T1a and T2b, with PSA levels less than 10 ng/ml.
  • Gleason score less than 3+4=7.
  • Chosen radiation therapy as the treatment for prostate cancer.
  • Signed consent form for the study.

Exclusion Criteria

  • Cancer stage T3 or higher.
  • Gleason score 4+3=7 or higher.
  • PSA levels greater than 10 ng/ml.
  • Cancer spread to lymph nodes or other parts of the body.
  • Previous prostate surgery, chemotherapy, or pelvic radiation.
  • Other cancers unless disease-free for at least 5 years, except for certain skin or bladder cancers.
  • History of inflammatory bowel disease.
  • Major medical or psychiatric conditions that could interfere with treatment or follow-up.

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