Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer (SPCG-15)
Prostatic Neoplasms
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Prostatic neoplasms, Locally advanced, Radiotherapy, Surgery, Mortality
Eligibility Criteria
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
Sites / Locations
- Aalborg University HospitalRecruiting
- Aarhus University HospitalRecruiting
- Rigshospitalet, Region h, Department OncologyRecruiting
- Rigshopsitalet Department urologyRecruiting
- Herlev HospitalRecruiting
- Odense University HospitalRecruiting
- Helsinki University Hospital, Department of UrologyRecruiting
- Tampere University Hospital, Pihlajalinna KoskiklinikkaRecruiting
- Turku University HospitalRecruiting
- Sørlandet HospitalRecruiting
- Oslo University Hospital, Department of radiation TherapyRecruiting
- Oslo University Hospital, Department UrologyRecruiting
- University Hospital of North NorwayRecruiting
- St. Olavs HospitalRecruiting
- Falu LasarettRecruiting
- Sahlgrenska University HospitalRecruiting
- Helsingborgs LasarettRecruiting
- Länssjukhuset RyhovRecruiting
- Kirurgkliniken, BlekingesjukhusetRecruiting
- Linköping University HospitalRecruiting
- Skåne University HospitalRecruiting
- Vrinevis Hospital
- Karolinska University HospitalRecruiting
- Capio St Göran HospitalRecruiting
- Sundvalls HospitalRecruiting
- Umeå University HospitalRecruiting
- Uppsala Akademiska HospitalRecruiting
- CentrallasarettetRecruiting
- Centrallasarettet Växjö HospitalRecruiting
- Östersund HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Prostatectomy/Surgery
Radiotherapy with adjuvant androgen deprivation therapy
Patients with locally advanced prostate adenocarcinoma recieves Prostatectomy/Surgery with or without adjuvant or salvage radiotherapy
Patients with locally advanced prostate adenocarcinoma treated with adjuvant androgen deprivation therapy