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

NCT02971358 | Recruiting

• 1 other identifier: 1461/2016
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Locally Advanced and Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

  90

Secondary Outcomes (1)

• Time to start androgen deprivation therapy

  2 years

Study Arms (1)

Radical prostatectomy arm

EXPERIMENTAL

In this arm the investigators will include patients with locally advanced or metastatic prostate cancer, who will undergo cytoreductive radical prostatectomy with extended lymph node dissection.

Procedure: Radical prostatectomy

Interventions

Radical prostatectomy PROCEDURE

Standard radical prostatectomy with extended lymph node dissection is performed.

Radical prostatectomy arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 20, 2016
• First Posted: November 22, 2016
• Study Start: August 1, 2016
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

AU (1)