Metastatic Prostate CarcinomaPhase 1NCT02458716
Cytoreductive Prostatectomy in Treating Patients With Newly Diagnosed, Metastatic Prostate Cancer
A Phase 1 study testing Robotic Assisted Radical Prostatectomy, Conventional open retropubic radical prostectomy and Laboratory Biomarker Analysis in people with Metastatic Prostate Carcinoma and Metastatic Prostatic Adenocarcinoma, run by Rutgers, The State University of New Jersey at 3 sites in United States.
Trial summary
This phase I trial studies the side effects of cytoreductive prostatectomy in treating patients with newly diagnosed prostate cancer that has spread from the primary site to other places in the body. Cytoreductive prostatectomy is a type of surgery that removes the prostate and as much of the tumor as possible. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Carcinoma, Metastatic Prostatic Adenocarcinoma, Prostate Carcinoma Metastatic to the Bone
- What is being tested?
- Robotic Assisted Radical Prostatectomy, Conventional open retropubic radical prostectomy and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Mar 2015to 14 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma of the prostate
- Evidence of lymph node or bone metastasis by magnetic resonance imaging (MRI)/computed tomography (CT), bone scan, or biopsy (N1Mx or NxM1)
- Give informed consent
- Clinical stage T3 or less (pelvic MRI shows no rectal and ureteral invasion)
- Cleared by the primary medical doctor for surgery
- No prior systemic therapy for metastatic prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Refuses to give informed consent
- Refuses or is unable to have pelvic MRI
- Clinical stage T4 (pelvic MRI shows rectal and/or ureteral invasion)
- Deemed a poor surgical risk per primary medical doctor
- Received prior therapeutic intervention for metastatic prostate cancer
- Known spinal cord compression or brain or liver metastasis
- Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
City of Hope National Medical Center (COH)
Duarte, California, 91010
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
University of California, Irvine (UCI)
Orange, California, 92868
About this study
Official title: Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed With Metastatic Prostate Cancer
This phase I trial studies the side effects of cytoreductive prostatectomy in treating patients with newly diagnosed prostate cancer that has spread from the primary site to other places in the body. Cytoreductive prostatectomy is a type of surgery that removes the prostate and as much of the tumor as possible. When combined with hormone therapy, robotic assisted radical prostatectomy (RARP) or conventional open retropubic radical prostatectomy (RRP) may prolong survival in patients with prostate cancer that has spread.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety and feasibility of cytoreductive prostatectomy (to remove as much of the primary cancer as possible) in men with newly diagnosed clinical T1-3N1M0 or T1-3N0M1a-b prostate cancer (herein, collectively referred to as metastatic prostate cancer).
SECONDARY OBJECTIVES:
- Time to prostate specific antigen (PSA) nadir and castration resistance following cytoreductive prostatectomy and subsequent standard systemic therapy, androgen deprivation.
OUTLINE:
Patients undergo RARP or conventional open RRP. Immediately following surgery, patients receive standard systemic androgen deprivation therapy.
After completion of study treatment, patients are followed up every 90 days for 3 years.
- Conditions
- Metastatic Prostate Carcinoma, Metastatic Prostatic Adenocarcinoma, Prostate Carcinoma Metastatic to the Bone
- Being tested
- Robotic Assisted Radical Prostatectomy, Conventional open retropubic radical prostectomy, Laboratory Biomarker Analysis, Quality-of-Life Assessment, ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted Radical ProstatectomyProcedure or surgery
Undergo RARP
Conventional open retropubic radical prostectomyProcedure or surgery
Undergo conventional open RRP
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)Drug
Also called Hormone therapy
LHRH agonist or antagonist (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
| Study group | Role | What they receive |
|---|---|---|
| Surgery followed by hormone therapy (ADT) | Experimental | Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy. Receives: Procedure: Robotic Assisted Radical Prostatectomy; Procedure: Conventional open retropubic radical prostectomy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Drug: ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major peri-operative complications defined as Clavien-Dindo grade III or higher
Rate will be calculated for the primary end point, and one-sided Binomial test will be used to compare the rate to the hypothesized value. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section.
Measured: Within 90 days after cytoreductive prostatectomy
Secondary outcomes (2)
Time to PSA nadir
Time to event data will be analyzed using the Kaplan-Meier product limit method. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section.
Measured: Up to 3 years
Time to rising PSA while on the standard androgen deprivation therapy
Time to event data will be analyzed using the Kaplan-Meier product limit method. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study start6 Mar 2015
- Primary completion14 Jan 2020
- Study completion14 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Responsible party
- Principal investigator, Isaac Yi Kim, MD, PhD, MBA, Rutgers Cancer Institute of New Jersey
- Investigators
- Isaac Kim, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458716
- Sponsor's protocol ID
- Pro20140001022
- Other IDs
- NCI-2015-00384, Pro20140001022, 081403, P30CA072720
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2015
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT02458716
- Acronym / sponsor ID
- Pro20140001022
- Conditions
- Metastatic Prostate Carcinoma, Metastatic Prostatic Adenocarcinoma, Prostate Carcinoma Metastatic to the Bone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- 6 Mar 2015 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 1 Jun 2015 (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.
This phase I trial studies the side effects of cytoreductive prostatectomy in treating patients with newly diagnosed prostate cancer that has spread from the primary site to other places in the body. Cytoreductive prostatectomy is a type of surgery that removes the prostate and as much of the tumor as possible. When combined with hormone therapy, robotic assisted radical prostatectomy (RARP) or conventional open retropubic radical prostatectomy (RRP) may prolong survival in patients with prostate cancer that has spread.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety and feasibility of cytoreductive prostatectomy (to remove as much of the primary cancer as possible) in men with newly diagnosed clinical T1-3N1M0 or T1-3N0M1a-b prostate cancer (herein, collectively referred to as metastatic prostate cancer).
SECONDARY OBJECTIVES:
- Time to prostate specific antigen (PSA) nadir and castration resistance following cytoreductive prostatectomy and subsequent standard systemic therapy, androgen deprivation.
OUTLINE:
Patients undergo RARP or conventional open RRP. Immediately following surgery, patients receive standard systemic androgen deprivation therapy.
After completion of study treatment, patients are followed up every 90 days for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery followed by hormone therapy (ADT) | Experimental | Procedure: Robotic Assisted Radical Prostatectomy, Procedure: Conventional open retropubic radical prostectomy, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Drug: ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically proven adenocarcinoma of the prostate
- Evidence of lymph node or bone metastasis by magnetic resonance imaging (MRI)/computed tomography (CT), bone scan, or biopsy (N1Mx or NxM1)
- Give informed consent
- Clinical stage T3 or less (pelvic MRI shows no rectal and ureteral invasion)
- Cleared by the primary medical doctor for surgery
Key exclusion criteria (7 listed)
- Refuses to give informed consent
- Refuses or is unable to have pelvic MRI
- Clinical stage T4 (pelvic MRI shows rectal and/or ureteral invasion)
- Deemed a poor surgical risk per primary medical doctor
- Received prior therapeutic intervention for metastatic prostate cancer
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 |
|---|---|---|
| Robotic Assisted Radical ProstatectomyUndergo RARP | Procedure or surgery | Surgery followed by hormone therapy (ADT) |
| Conventional open retropubic radical prostectomyUndergo conventional open RRP | Procedure or surgery | Surgery followed by hormone therapy (ADT) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Surgery followed by hormone therapy (ADT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Surgery followed by hormone therapy (ADT) |
| ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)Also: Hormone therapyLHRH agonist or antagonist (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide) | Drug | Surgery followed by hormone therapy (ADT) |
Primary outcome
Rate of major peri-operative complications defined as Clavien-Dindo grade III or higher
Time frame: Within 90 days after cytoreductive prostatectomy
Rate will be calculated for the primary end point, and one-sided Binomial test will be used to compare the rate to the hypothesized value. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section.
2 secondary outcomes
Time to PSA nadir
Time frame: Up to 3 years
Time to rising PSA while on the standard androgen deprivation therapy
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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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. This study is not recruiting at the moment.
Isaac Kim principal investigator
Rutgers Cancer Institute of New Jersey
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Robotic Assisted Radical Prostatectomy, Conventional open retropubic radical prostectomy and Laboratory Biomarker Analysis in people with Metastatic Prostate Carcinoma and Metastatic Prostatic Adenocarcinoma, run by Rutgers, The State University of New Jersey at 3 sites in United States.
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 7 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: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major peri-operative complications defined as Clavien-Dindo grade III or higher (time frame: Within 90 days after cytoreductive prostatectomy). 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 8 Apr 2021.