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Home»Prostate cancer» Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy
Clinical Trial
Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy
This phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising prostate specific antien (PSA) after prostatectomy (surgery for prostate cancer).
The details
Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens (male sex hormones such as testosterone) can cause the growth of prostate cancer cells. Androgen deprivation therapy, or antihormone therapy, such as flutamide (Eulexin), bicalutamide (Casodex), and luteinizing hormone-releasing hormone agonist may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy with or without androgen-deprivation therapy is more effective for prostate cancer.
Who are they looking for?
This trial will enrol 1,764 patients aged 18 years or over with adenocarcinoma of the prostate treated mainly with radical prostatectomy. Post-prostatectomy PSA should be ≥ 0.1 and ≤ 1.0 ng/mL at least 6 weeks after prostatectomy. The cancer must be stage T2 or T3 (early stage), have a Gleason score of 9 or less and be lymph node negative with no distant metastases (spread of cancer).
Patients should have no prior invasive malignancy and no severe, active co-morbidity (additional disease other than prostate cancer). Patients should not have undertaken androgen-deprivation therapy for greater than 6 months prior to prostatectomy or after prostatectomy. Patients should not have undertaken chemotherapy, brachytherapy or pelvic radiotherapy.
How will it work
The trial will mainly assess freedom from progression, in particular biochemical failure (defined as PSA rising 2ng/mL or higher from the lowest value seen after prostatectomy), clinical failure (leturn of the tumor) or death from any cause. Patients will be randomly assigned to one of three groups:
Group I: Prostate bed radiotherapy alone (radiotherapy directed towards the area below the bladder in front of the rectum).
Group II: Prostate bed radiotherapy and androgen-deprivation therapy. Androgen-deprivation therapy will include either flutamide or bicalutamide.
Group III: Prostate bed radiotherapy, androgen-deprivation therapy and pelvic lymph node radiotherapy.
