Locally Advanced and Metastatic Prostate CancerNCT02971358
Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer
A study testing Radical prostatectomy in people with Locally Advanced and Metastatic Prostate Cancer, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Locally Advanced and Metastatic Prostate Cancer
- What is being tested?
- Radical prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2016to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Clinically no visceral metastasis
- Male, >18 Jahre
- Fit for surgery
- ECOG Performance Status 0 oder 1
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Bernhard Grubmüller, MD, 004314040026150, bernhard.grubmueller@meduniwien.ac.at
About this study
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
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.
- Being tested
- Radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical prostatectomyProcedure or surgery
Standard radical prostatectomy with extended lymph node dissection is performed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification)
Measured: 90
Secondary outcomes (1)
Time to start androgen deprivation therapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced and Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Bernhard Grubmüller, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971358
- Sponsor's protocol ID
- 1461/2016
- Status last verified
- May 2025
- First submitted
- 20 Nov 2016
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02971358
- Acronym / sponsor ID
- 1461/2016
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radical prostatectomy arm | Experimental | Procedure: Radical prostatectomyIn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- Male, < 18 Jahre
- > 5 bone metastasis
- > 75 years
- No ability for informed consent
- Clinically infiltration into the rectum or pelvic wall
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical prostatectomyStandard radical prostatectomy with extended lymph node dissection is performed. | Procedure or surgery | Radical prostatectomy arm |
Primary outcome
The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification)
Time frame: 90
1 secondary outcome
Time to start androgen deprivation therapy
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical prostatectomy in people with Locally Advanced and Metastatic Prostate Cancer, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of perioperative complications within 90 days after surgery (Clavien-Dindo-classification) (time frame: 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.