Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Prostatectomy/Surgery
  Radical prostatectomy with or without adjuvant or salvage radiotherapy
• Другое Radiotherapy with adjuvant androgen deprivation therapy
  Radiotherapy with adjuvant androgen deprivation therapy

Первичные конечные точки

• Cause specific survival [Срок оценки: Up to 10 years]

Вторичные конечные точки (7)

• Metastasis free survival [Срок оценки: Up to 10 years]
• Quality of life - general psychological, urinary, bowel and sexual health [Срок оценки: At 1,2,5 and 10 years after randomization]
• Overall survival [Срок оценки: Up to 10 years]
• Time to castration-resistant prostate cancer [Срок оценки: Up to 10 years]
• Time to biochemical progression [Срок оценки: Up to 10 years]
• Adverse events [Срок оценки: Up to 10 years]
• Cardiovascular disease [Срок оценки: Up to 10 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 16 центров

• Falu Lasarett — Falun
• Sahlgrenska University Hospital — Gothenburg
• Helsingborgs Lasarett — Helsingborg
• Länssjukhuset Ryhov — Jönköping
• Kirurgkliniken, Blekingesjukhuset — Karlskrona
• Linköping University Hospital — Linköping
• Skåne University Hospital — Malmö
• Vrinevis Hospital — Norrköping
• … и ещё 8 центров

Дания · 6 центров

• Aalborg University Hospital — Aalborg
• Aarhus University Hospital — Aarhus
• Rigshospitalet, Region h, Department Oncology — Copenhagen
• Rigshopsitalet Department urology — Copenhagen
• Herlev Hospital — Herlev
• Odense University Hospital — Odense

Норвегия · 5 центров

• Sørlandet Hospital — Kristiansand
• Oslo University Hospital, Department of radiation Therapy — Oslo
• Oslo University Hospital, Department Urology — Oslo
• University Hospital of North Norway — Tromsø
• St. Olavs Hospital — Trondheim

Финляндия · 3 центра

• Helsinki University Hospital, Department of Urology — Helsinki
• Tampere University Hospital, Pihlajalinna Koskiklinikka — Tampere
• Turku University Hospital — Turku

Идентификаторы

NCT: NCT02102477 · SPCG-15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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