RecruitingNot ApplicableNCT02102477

Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer

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


Sponsor

Olof Akre

Enrollment

1,200 participants

Start Date

Oct 1, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two treatments for locally advanced prostate cancer: surgery (removal of the prostate) versus radiation therapy, to find out which approach leads to better long-term outcomes for patients. **You may be eligible if...** - You are 75 or younger - You have been newly diagnosed with prostate cancer that has grown beyond the prostate capsule (stage T3 or T4) but has not spread to distant organs - There are no signs of cancer in nearby lymph nodes or distant body parts - Your cancer has a Gleason grade 4 or 5 pattern (indicating higher aggressiveness) - You have not yet received any treatment for this diagnosis **You may NOT be eligible if...** - Your PSA level is above 100 ng/mL - You have a condition that makes either surgery or radiation unsafe - You have bowel conditions like Crohn's disease, ulcerative colitis, or anal fistulas (which can complicate radiation) - You have another medical condition that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREProstatectomy/Surgery

Radical prostatectomy with or without adjuvant or salvage radiotherapy

OTHERRadiotherapy with adjuvant androgen deprivation therapy

Radiotherapy with adjuvant androgen deprivation therapy


Locations(30)

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

Malmö, 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

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NCT02102477


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