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

Sponsor

Medical University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT02971358

Collaborator

(none)

200

Enrollment

Location

Arm

136

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced and Metastatic Prostate Cancer	Procedure: Radical prostatectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Radical prostatectomy Standard radical prostatectomy with extended lymph node dissection is performed.

Arm

Intervention/Treatment

Experimental: 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.

Procedure: Radical prostatectomy

Standard radical prostatectomy with extended lymph node dissection is performed.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Time to start androgen deprivation therapy [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Bernhard Grubmüller, MD, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT02971358

Other Study ID Numbers:

1461/2016

First Posted:

Nov 22, 2016

Last Update Posted:

Apr 5, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Apr 5, 2022