Comparing surgery and radiotherapy for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.