Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
MALE
NCT02971358

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

Led by Medical University of Vienna · Updated on 2025-05-14

200

Participants Needed

1

Research Sites

747 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 18 to 75 years
  • Diagnosed with adenocarcinoma of the prostate
  • Very high risk prostate cancer (PSA ≥ 20 or Gleason Score ≥ 8 or tumor stage ≥ cT3) and/or oligometastatic prostate cancer (any T stage, N positive, any M stage, or any T, any N, M positive)
  • Five or fewer bone metastases
  • Able to provide informed consent
  • No clinical infiltration into the rectum or pelvic wall
  • No clinical visceral metastasis
  • Fit for surgery
  • ECOG Performance Status of 0 or 1
Not Eligible

You will not qualify if you...

  • Male younger than 18 years
  • More than 5 bone metastases
  • Older than 75 years
  • Unable to provide informed consent
  • Clinical infiltration into the rectum or pelvic wall
  • Not fit for surgery
  • Clinical visceral metastasis

AI-Screening

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Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, Austria, 1090

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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