Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer
A legfontosabb adatok
- Hol
- Helsinki, Tampere és Turku (Finnország)Mind a 3 helyszín megnézése
AI-kivonat: kiket keres a vizsgálat
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat 75 évesnél fiatalabb vagy 75 éves, kezeletlen, lokálisan előrehaladott (T3) prosztatarákos férfiakat keres, akiknél nincs távoli áttét jele. A műtétet hasonlítja össze a sugárkezeléssel.
- Életkor
- 18 és 75 év között
- Nem
- Csak férfiak
- A betegség stádiuma
- Szövettanilag igazolt, kezeletlen prosztata-adenokarcinóma, T3 stádium (T4, ha MR-vizsgálaton kezelhetőnek ítélik), nincs távoli áttét (M0), nincs megnagyobbodott nyirokcsomó (N0), jelen van a 4-es vagy 5-ös Gleason-mintázat.
- Korábbi kezelés
- A prosztatarákot korábban nem kezelték. A kismedencei terület korábbi sugárkezelése miatt nem lehet részt venni.
A részvétel fő kizáró okai
- 100 ng/mL feletti PSA-érték
- Bármilyen állapot, amely miatt a műtét vagy a prosztata sugárkezelése nem biztonságos
- Végbél- és anális betegség, például sipoly, Crohn-betegség vagy fekélyes vastagbélgyulladás
- Korábbi sugárkezelés a kismedencei területen
- Altatással kapcsolatos ellenjavallat
Gépi kiolvasás: 2026. november 12.
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 75 év között vagy?
Forrás: NCT02102477: ki vehet részt
Helyszínek itt: Finnország
- Helsinki University Hospital, Department of UrologyHelsinki, FinnországContact: Antti Rannikko, M.D ass profRésztvevőt keres
- Tampere University Hospital, Pihlajalinna KoskiklinikkaTampere, FinnországContact: Teuvo Tammela, M.D.Résztvevőt keres
- Turku University HospitalTurku, FinnországContact: Peter Boström, M.D.Résztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Olof Akre
- Azonosító
- NCT02102477
- A regiszteradat frissítve
- 2022. március 31.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial
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 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.
Bevonási feltételek: 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.
Kizáró feltételek: Previous radiotherapy to the pelvic region; On the other hand, surgery may be precluded among patients with:; 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; Patients with a PSA value of > 100 ng/mL; Significant obstructive lower urinary tract symptoms; Proximal stricture of the urethrae; Severe neurogenic bladder dysfunction; Enlarged prostate beyond 70-90 ml; Massive local tumor progression, particularly in the apical region; Massive abdominal obesity; Contraindications to anesthesia.