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

NCT ID: NCT02971358

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2030-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radical prostatectomy arm

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.

Group Type: EXPERIMENTAL

Radical prostatectomy

Intervention Type: PROCEDURE

Standard radical prostatectomy with extended lymph node dissection is performed.

Interventions

Radical prostatectomy

Standard radical prostatectomy with extended lymph node dissection is performed.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Dr. Bernhard Grubmüller

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Bernhard Grubmüller, MD

Role: primary

bernhard.grubmueller@meduniwien.ac.at

004314040026150

Other Identifiers

1461/2016

Identifier Type: -

Identifier Source: org_study_id