Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer
NCT ID: NCT02102477
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1200 participants
INTERVENTIONAL
2014-10-31
2045-12-31
Brief Summary
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One potential advantage of adding prostatectomy to the treatment of LAPC is that removing the prostate enables a full pathological assessment of the tumor characteristics and thus a better estimation of the risk of recurrence. Surgical treatment could thus reduce the numbers needed to treat with chemotherapy and radiation, and thus improve quality of life after treatment. In addition, evidence indicate that residual cancer in the prostate occurs in 25% after radiation treatment (56) and surgical removal of the prostate may improve survival beyond what can be achieved by radiation and ADT. On the other hand, patients treated with surgery, radiation and hormones will experience side effects of all three treatment modalities and might fare better if radiotherapy plus hormones can provide oncological control without prior surgery.
A randomized clinical trial comparing two multimodal treatment regimens of which one includes a radical prostatectomy is therefore warranted.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prostatectomy/Surgery
Patients with locally advanced prostate adenocarcinoma recieves Prostatectomy/Surgery with or without adjuvant or salvage radiotherapy
Prostatectomy/Surgery
Radical prostatectomy with or without adjuvant or salvage radiotherapy
Radiotherapy with adjuvant androgen deprivation therapy
Patients with locally advanced prostate adenocarcinoma treated with adjuvant androgen deprivation therapy
Radiotherapy with adjuvant androgen deprivation therapy
Radiotherapy with adjuvant androgen deprivation therapy
Interventions
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Prostatectomy/Surgery
Radical prostatectomy with or without adjuvant or salvage radiotherapy
Radiotherapy with adjuvant androgen deprivation therapy
Radiotherapy with adjuvant androgen deprivation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
MALE
No
Sponsors
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Olof Akre
OTHER
Responsible Party
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Olof Akre
Professor
Principal Investigators
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Johan Stranne, M.D ass prof
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital, Department of Urology, SE- 413 45 Gothenburg
Camilla Thellenberg Karlsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Umeå University Hospital, Department of Radiation Science, SE-901 87 Umeå Sweden
Eva M Johansson, R.N PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institute, Nobelsväg, SE- 171 77 Solna, Sweden
Gunnar Steineck, M.D Prof
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institute, Nobelsväg, SE-171 77 Solna, Sweden
Klaus Brasso, M.D
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, department Urology, DK-2001-Copenhagen, Denmark
Peter M Meidahl Petersen, M.D ass prof
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Region h, Department of Oncology, Blegdamsvej 9, DK- 2001, Copenhagen, Denmark
Bjørn Brennhovd, M.D ass.prof
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital, Department of Urology, P.O Box 4950 Nydalen, N-0424, Oslo Norway
Wolfgang Lilleby, M.D ass.prof
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital, Department of Radiation Therapy, P.O Box 4950, N-0424, Nydalen Oslo, Norway
Antti Rannikko, M.D ass.prof
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital, Department Urology,Stenbäckinkatu 9, FIN-00290 Helsinki , Finland
Mauri Kouri, M.D PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital, Department Urology,Stenbäckinkatu 9, FIN-00290 Helsinki , Finland
Tuomas Mirtti, M.D PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital, Department Urology,Stenbäckinkatu 9, FIN-00290 Helsinki , Finland
Locations
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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
Turku University Hospital
Turku, , Finland
Sørlandet Hospital
Kristiansand, , Norway
Oslo University Hospital, Department of radiation Therapy
Oslo, , Norway
Oslo University Hospital, Department Urology
Oslo, , Norway
University Hospital of North Norway
Tromsø, , Norway
St. Olavs Hospital
Trondheim, , Norway
Falu Lasarett
Falun, , Sweden
Sahlgrenska University Hospital
Gothenburg, , Sweden
Helsingborgs Lasarett
Helsingborg, , Sweden
Länssjukhuset Ryhov
Jönköping, , Sweden
Kirurgkliniken, Blekingesjukhuset
Karlskrona, , Sweden
Linköping University Hospital
Linköping, , Sweden
Skåne University Hospital
Malmo, , Sweden
Vrinevis Hospital
Norrköping, , Sweden
Östersund Hospital
Östersund, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Capio St Göran Hospital
Stockholm, , Sweden
Sundvalls Hospital
Sundsvall, , Sweden
Umeå University Hospital
Umeå, , Sweden
Uppsala Akademiska Hospital
Uppsala, , Sweden
Centrallasarettet
Vaxjo, , Sweden
Centrallasarettet Växjö Hospital
Vaxjo, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Niels Harving, M.D.
Role: primary
Lise Bentzen, M.D.
Role: primary
Peter M Meidahl Petersen, M.D ass
Role: primary
Klaus Brasso, M.D
Role: primary
Henrik Jacobsen, M.D.
Role: primary
Steinbjørn Hansen, M.D.
Role: primary
Antti Rannikko, M.D ass prof
Role: primary
Teuvo Tammela, M.D.
Role: primary
Peter Boström, M.D.
Role: primary
Christoph Müller, Ph.D. M.D.
Role: primary
Wolfgang Lilleby, M.D ass prof
Role: primary
Bjorn Brennhovd, M.D ass prof
Role: primary
Hege Sagstuen, Ph.D.
Role: primary
Torgrim Tandstad, Ph.D.
Role: primary
Hampus Nugin, MD
Role: primary
Johan Stranne, ass prof
Role: primary
Konstantinos Lentaris, MD
Role: primary
Anders Jonsson, MD
Role: primary
Amer Mousa Kadhem, M.D.
Role: primary
Per Skoglund, M.D.
Role: primary
Anders Bjartell, MD
Role: primary
Andreas Lundgren, MD
Role: primary
Olof Akre, Prof
Role: primary
Lillemor Nygren, M.D.
Role: primary
Johan Styrke, M.D.
Role: primary
Camilla Thellenberg, M.D PhD
Role: primary
Eva Johanssson, M.D
Role: primary
Amer Elwaheidy, MD
Role: primary
Amer Elwaheidy, M.D.
Role: primary
Other Identifiers
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SPCG-15
Identifier Type: -
Identifier Source: org_study_id
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