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

Not Applicable

Recruiting

• Conditions: Locally Advanced and Metastatic Prostate Cancer
• Interventions: Procedure: Radical prostatectomy

• Registration Number: NCT02971358
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-11-20
• Study First Submitted QC: 2016-11-20
• Study First Posted: 2016-11-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radical prostatectomy arm	Radical prostatectomy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to start androgen deprivation therapy	2 years

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria