Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial


Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02102477

Sponsor: Olof Akre

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: Male

Inclusion Criteria:

  • Age ≤75, at the time of randomization
  • Diagnosed histopathologically confirmed and untreated prostatic adenocarcinoma
  • The general condition and mental status of patients shall permit observation in accordance with the study protocol
  • Tumor stage (T, M, N): T3 stage (as indicated by digital rectal examination or MR imaging or other validated imaging technique) T4 tumors can be included if considered resectable/treatable on MR imaging Significant extra-capsular tumor extension in biopsy (rare but acceptable for inclusion) M0 (no sign of distant metastases) confirmed by bone scan or CT or MRT of axial skeleton (at a maximum of pelvis and lumbar vertebral column) N0 stage, defined in accordance to the RECIST guidelines as no sign of macroscopic retroperitoneal lymph-node metastases >=1.5 cm (short axis) on CT scan, PET-CT, or MRT or more than one suspected lymph-node metastases Presence Gleason grade pattern 4 or 5
  • Signed Informed consent

Exclusion Criteria:

  • Patients with a PSA value of > 100 ng/mL
  • Any medical condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives Patients with contraindications for either prostatectomy or radiotherapy to the prostate are not eligible for the study. Most contraindications for these treatments are relative, but in general, radiotherapy may be precluded among patients with:
  • Anorectal disease, such as fistulae, Crohn´s disease, and ulcerative colitis
  • Significant obstructive lower urinary tract symptoms
  • Proximal stricture of the urethrae
  • Severe neurogenic bladder dysfunction
  • Enlarged prostate beyond 70-90 ml
  • Previous radiotherapy to the pelvic region On the other hand, surgery may be precluded among patients with:
  • Massive local tumor progression, particularly in the apical region
  • Massive abdominal obesity
  • Contraindications to anesthesia

View trial on ClinicalTrials.gov


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