Study on Radiation Therapy and Hormone Therapy for Patients with Rising PSA After Prostate Cancer Surgery

Sponsor: Radiation Therapy Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT00567580

Provider View

This clinical trial is exploring different combinations of radiation and hormone therapies to see which is more effective in treating patients whose PSA levels are rising after prostate cancer surgery.

Patient Parameters

Program Overview

This study aims to find out if adding hormone therapy to radiation treatment can better control prostate cancer in patients who have rising PSA levels after surgery. The trial will compare the effectiveness of radiation therapy alone versus radiation combined with short-term hormone therapy, and also look at the effects of adding pelvic lymph node radiation.

Description

The main goal of this study is to determine if combining short-term hormone therapy with radiation to the prostate area can help prevent the progression of prostate cancer in patients who have had surgery but now have rising PSA levels. The study will also explore if adding radiation to the pelvic lymph nodes provides additional benefits.

Secondary goals include comparing the rates of cancer returning, the development of resistance to hormone therapy, the spread of cancer to distant sites, and survival rates over five years. The study will also assess the side effects of the treatments and their impact on quality of life.

Participants will be randomly assigned to one of three treatment groups. Follow-up visits will occur at 3, 6, and 12 months after completing radiation therapy, then every 6 months for 6 years, and annually thereafter.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer and treated with surgery, with no cancer found in lymph nodes or lymph node status unknown.
  • PSA levels between 0.1 and 2.0 ng/mL at least 6 weeks after surgery.
  • Specific classifications of cancer stage and Gleason score.
  • Good overall health with a performance status of 0-1.
  • Age 18 or older.
  • No evidence of cancer spread to distant sites based on recent medical exams and scans.
  • Adequate blood cell counts and liver function.
  • Testosterone levels within a certain range.
  • Willing to sign informed consent to participate in the study.

Exclusion Criteria

  • Any signs of cancer recurrence in the prostate area unless proven otherwise by biopsy.
  • Enlarged pelvic lymph nodes unless proven cancer-free by biopsy.
  • Previous hormone therapy for more than 6 months before surgery.
  • Hormone therapy started after surgery and before joining the study.
  • Previous chemotherapy or other treatments for prostate cancer.
  • Previous radiation therapy to the pelvis.
  • History of other cancers unless disease-free for at least 5 years.
  • Severe health conditions such as heart disease, infections, or liver problems.
  • Allergic reactions to the study drugs.

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