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OpenTrials
Completed

NCT Number: NCT01578356

Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery

For primary surgical treatment of prostate cancer the investigators compare the classic open surgery (radical retropubic prostatectomy, RRP) versus robot-assisted laparoscopic surgery (RALP). Oncological results are obtained at standard follow-up consultations through Prostate-Specific Antigen (PSA) measurement to detect biochemical recurrence. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Currently the investigators perform all of their prostatectomies in a robot-assisted manner. For results of the open surgery the investigators send questionnaires to patients who had the operation in the past.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • prostate cancer
  • radical retropubic prostatectomy or
  • robot-assisted laparoscopic surgery

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Biochemical recurrence at follow-up.

    Time frame: 3 months after prostatectomy

    PSA measurement in the serum should not be > or = 0,20 ng/ml.

  2. Biochemical recurrence at follow-up

    Time frame: 6 months after prostatectomy

    PSA measurement in the serum should not be > or = 0,20 ng/ml.

  3. Biochemical recurrence at follow-up.

    Time frame: 9 months after prostatectomy

    PSA measurement in the serum should not be > or = 0,20 ng/ml.

  4. Biochemical recurrence at follow-up.

    Time frame: 1 year after prostatectomy

    PSA measurement in the serum should not be > or = 0,20 ng/ml.

  5. Biochemical recurrence at follow-up.

    Time frame: 6-monthly follow up between 1 and 5 years after prostatectomy.

    PSA measurement in the serum should not be > or = 0,20 ng/ml.

Secondary outcomes

  1. Functional assessment concerning continence.

    Time frame: after 1, 3, 12 and 24 months

    Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.

  2. Functional assessment concerning potency.

    Time frame: after 1, 3, 12 and 24 months

    Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.

  3. Functional assessment concerning quality of life.

    Time frame: after 1, 3, 12 and 24 months

    Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Apr 16, 2012
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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