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NCT Number: NCT02971358

Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer

Prostate cancer is the most common non-skin cancer diagnosed among men and the second leading cause of male cancer deaths in the United States. In 2013, it is estimated that 29,270 men have died from prostate cancer. Although radiation and surgery are quite effective for localized disease, there is no effective cure for men who present with metastatic prostate cancer as the 5-year relative survival rate is only 28%.

Currently, androgen deprivation therapy (ADT) via medical or surgical castration is the standard first-line therapy in men with metastatic disease but castration-recurrent prostate cancer (CRPC) eventually emerges with a median time of 18-24 months. Once CRPC develops, secondary hormonal manipulation, chemotherapy, and immunotherapy are marginally effective.

Given the dismal prognosis of metastatic prostate cancer, new ideas and novel approaches must be explored to improve the clinical outcome. In this regard, recently emerging data suggest that local tumor control may enhance the effectiveness of subsequent systemic therapies. Therefore, in this proposal, the investigators have designed a Phase I/II study in which they will prospectively evaluate the safety and feasibility of cytoreductive prostatectomy in men with newly diagnosed mPCa.

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Key information

Conditions

Locally Advanced and Metastatic 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–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Bernhard Grubmüller, MD

CONTACT

[email protected]

004314040026150

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adenocarcinoma of the prostate
  • Very high risk PCA (PSA ≥ 20 oder Gleason Score ≥ 8 oder ≥ cT3) and/or oligometastasierte PCA (T any N positive M any, oder T any N any M positive)
  • ≤5 bone metastasis
  • ≤75 years
  • Ability for informed consent
  • Clinically no infiltration into the rectum or pelvic wall
  • Clinically no visceral metastasis
  • Male, >18 Jahre
  • Fit for surgery
  • ECOG Performance Status 0 oder 1

Exclusion criteria

  • Male, < 18 Jahre
  • > 5 bone metastasis
  • > 75 years
  • No ability for informed consent
  • Clinically infiltration into the rectum or pelvic wall
  • Not fit for surgery
  • Clinically visceral metastasis

Treatment and study plan

radical prostatectomy

Procedure

Standard radical prostatectomy with extended lymph node dissection is performed.

Primary outcomes

  1. The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification)

    Time frame: 90

Secondary outcomes

  1. Time to start androgen deprivation therapy

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer - a Prospective Single Center Phase I/II Study

Important dates

Study start
2016
Primary completion
2028
Study completion
2030
First posted
Nov 22, 2016
Registry last updated
May 14, 2025

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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