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โ† Trials
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Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer

RecruitingNAAges 18 Years - 75 YearsMaleOlof Akre
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In plain words

What the trial is, and whether it could suit you

This prospective, open randomized phase III surgical trial seeks to study whether radical prostatectomy (with or without the combination of external radiation) improves prostate-cancer specific survival in comparison with primary radiation treatment and hormonal treatment among patients diagnosed with locally advanced (T3) prostate cancer. Untreated or conservatively treated locally advanced prostate cancer is associated with high mortality. Modern curative treatment for advanced solid malign tumors include surgery and/or radiation plus attempted chemotherapy if available to achieve both local control and elimination of potential micro metastases. Whereas there is evidence that surgery can cure localized prostate cancer, there are no clinical trials of multi-modal treatment of locally advanced prostate cancer that includes surgical removal of the prostate. One potential advantage of add

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ค75, 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, Crohnยดs 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
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What it tests

  • Prostatectomy/Surgery
  • Radiotherapy with adjuvant androgen deprivation therapy
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Where

30 sites
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet, Region h, Department Oncology
Copenhagen, Denmark
Rigshopsitalet Department urology
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Odense University Hospital
Odense, Denmark
Helsinki University Hospital, Department of Urology
Helsinki, Finland
Tampere University Hospital, Pihlajalinna Koskiklinikka
Tampere, Finland

โ€ฆand 22 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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