This phase 3 trial aims to determine the effectiveness of different ways of performing prostate cancer surgery. The main outcomes to be investigated are surgical complications and cancer recurrence. The trial is recruiting in New Jersey and New York (USA).
The details
Surgery to remove the prostate (also known as radical prostatectomy) is a common treatment for localized prostate cancer. Advances in surgical techniques have led to prostate surgeries being more efficient and easier to tolerate. However, the evidence is mixed with regards to the whether the lymph nodes near the prostate should also be removed in preventing cancer recurrence. In addition, there is no agreement on whether the type of incision (vertical or horizontal) affects the likelihood of the patient developing a hernia. A hernia is a type of complication, referring to abdominal tissue protruding through the incision, creating a small bulge that has to be surgically corrected. Doctors are also unsure of whether a short (1 day) or longer (3 day) course of antibiotics should be given to prevent infection after surgery.
This study will examine these different ways of performing prostate surgery in preventing surgical complications and reducing cancer recurrence. Surgical complications will be measured by means of questionnaires. Cancer recurrence will be measured by blood tests indicating prostate growth, or the need for additional treatment 6 months or more after prostate surgery.
Who are they looking for?
This study will recruit about 1400 men with prostate cancer, who are scheduled for prostate surgery at the study’s treatment center. Participants should be aged 21 years or older.
Once the inclusion criteria are met, there are no exclusion criteria noted for participating in this trial.
How will it work
In one group, participants will be randomly allocated to either undergo prostate surgery with normal or modified local lymph node removal. In another group, participants will be randomly assigned to either receive a vertical or a horizontal incision during surgery. In a third group, participants will be randomly assigned to receive either a short (1 day) or a longer (3 day) course of antibiotics after surgery.
Complications within 1 year after surgery will be recorded with questionnaires completed by the participants. The presence of urinary tract infections within 10 days after surgery will also be recorded. Cancer recurrence will be determined by means of blood tests indicating prostate growth, or the need for additional treatment 6 months or more after prostate surgery. Cancer recurrence will be recorded for up to 2 years after surgery.
