Comparing surgery and radiotherapy for advanced prostate cancer
Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial
This study is testing if surgery combined with radiation can help men with advanced prostate cancer live longer compared to just using radiation and hormone therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Karolinska University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 30 sites (Aalborg and 29 other locations) |
| Trial ID | NCT02102477 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine whether radical prostatectomy, with or without external radiation, improves survival rates compared to primary radiation treatment and hormonal therapy in patients with locally advanced prostate cancer. It is a prospective, open randomized phase III trial that focuses on patients diagnosed with untreated prostatic adenocarcinoma at T3 stage. The study seeks to explore the potential benefits of surgical intervention in conjunction with radiation therapy to enhance treatment outcomes for this high-mortality condition.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 75 or younger with untreated, histopathologically confirmed locally advanced prostate cancer.
Not a fit: Patients with distant metastases or those with significant comorbidities that prevent them from undergoing surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option that improves survival rates for patients with locally advanced prostate cancer.
How similar studies have performed: While surgery has shown efficacy in localized prostate cancer, this approach for locally advanced cases is novel and has not been extensively tested in clinical trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalborg and 29 other locations
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Rigshospitalet, Region h, Department Oncology — Copenhagen, Denmark (Recruiting)
- Rigshopsitalet Department urology — Copenhagen, Denmark (Recruiting)
- Herlev Hospital — Herlev, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
- Helsinki University Hospital, Department of Urology — Helsinki, Finland (Recruiting)
- Tampere University Hospital, Pihlajalinna Koskiklinikka — Tampere, Finland (Recruiting)
- Turku University Hospital — Turku, Finland (Recruiting)
- Sørlandet Hospital — Kristiansand, Norway (Recruiting)
- Oslo University Hospital, Department of radiation Therapy — Oslo, Norway (Recruiting)
- Oslo University Hospital, Department Urology — Oslo, Norway (Recruiting)
- University Hospital of North Norway — Tromsø, Norway (Recruiting)
- St. Olavs Hospital — Trondheim, Norway (Recruiting)
- Falu Lasarett — Falun, Sweden (Recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Helsingborgs Lasarett — Helsingborg, Sweden (Recruiting)
- Länssjukhuset Ryhov — Jönköping, Sweden (Recruiting)
- Kirurgkliniken, Blekingesjukhuset — Karlskrona, Sweden (Recruiting)
- Linköping University Hospital — Linköping, Sweden (Recruiting)
- Skåne University Hospital — Malmö, Sweden (Recruiting)
- Vrinevis Hospital — Norrköping, Sweden (Terminated)
- Östersund Hospital — Östersund, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
- Capio St Göran Hospital — Stockholm, Sweden (Recruiting)
- Sundvalls Hospital — Sundsvall, Sweden (Recruiting)
- Umeå University Hospital — Umeå, Sweden (Recruiting)
- Uppsala Akademiska Hospital — Uppsala, Sweden (Recruiting)
- Centrallasarettet — Vaxjo, Sweden (Recruiting)
- Centrallasarettet Växjö Hospital — Vaxjo, Sweden (Recruiting)
Study contacts
- Principal investigator: Johan Stranne, M.D ass prof — Sahlgrenska University Hospital, Department of Urology, SE- 413 45 Gothenburg
- Study coordinator: Olof Akre, Prof.
- Email: olof.akre@ki.se
- Phone: +46-8-517 700 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.