Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02971358 |
Recruitment Status :
Recruiting
First Posted : November 22, 2016
Last Update Posted : April 5, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | August 2016 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2027 |

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. |
- The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification) [ Time Frame: 90 ]
- Time to start androgen deprivation therapy [ Time Frame: 2 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971358
Austria | |
Medical University of Vienna | Recruiting |
Vienna, Austria, 1090 | |
Contact: Bernhard Grubmüller, MD 004314040026150 bernhard.grubmueller@meduniwien.ac.at |
Responsible Party: | Dr. Bernhard Grubmüller, MD, Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT02971358 |
Other Study ID Numbers: |
1461/2016 |
First Posted: | November 22, 2016 Key Record Dates |
Last Update Posted: | April 5, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |