AzTrials
AzTrials

Stage IV Prostate Adenocarcinoma AJCC v7Phase 2NCT03456843

Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer

A Phase 2 study testing Antiandrogen Therapy, Docetaxel and Laboratory Biomarker Analysis in people with Stage IV Prostate Adenocarcinoma AJCC v7, run by Yale University at 16 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a phase 2.5 international, multi-institution, randomized clinical trial to evaluate the potential therapeutic effect of CRP combined with the BST in men with mPCa prospectively. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Stage IV Prostate Adenocarcinoma AJCC v7
What is being tested?
Antiandrogen Therapy, Docetaxel and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
16 sitesin 6 countries
Study dates
20 Mar 2018to Mar 2027
Phase
Phase 2
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 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 metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
  • Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis.
  • If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET [positron emission tomography], bone scan and MRI, modality at the discretion of the treating physician)
  • No previous local therapy for prostate cancer (i.e prostate radiation, cryotherapy, etc.)
  • Give informed consent
Show all 13Show fewer
  • Prostate deemed resectable by surgeon
  • Plans to start or has already started ADT no longer than 6 months prior to consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Hemoglobin (HgB) >= 9 g/dL compatible for surgery
  • Platelets > 80,000/mcL compatible for surgery
  • Aspartate aminotransferase (AST) =< 2x upper limit of normal (ULN) compatible for surgery
  • Alanine aminotransferase (ALT) =< 2x upper limit of normal (ULN) compatible for surgery

Who cannot join

  • Refuses to give informed consent
  • Deemed to have unresectable disease by surgeon
  • Received ADT for more than 6 months prior to consent
  • Life expectancy of less than 6 months prior to consent
  • Active spinal cord compression
  • Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to consent
  • Previous local therapy for prostate cancer
  • Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent

Trial locations and contacts

16 sites in 6 countries.

16 sites in 6 countries

United States7 sites

  • City of Hope

    Duarte, California, 91010

  • University of California, Irvine

    Irvine, California, 92697

  • University of Southern California

    Los Angeles, California, 90033

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale University

    New Haven, Connecticut, 06519

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Swedish Medical Services

    Seattle, Washington, 98104

Other trials in United States

Japan3 sites

  • Akita University

    Akita

  • Kindai University

    Ōsaka-sayama, Osaka, 589-8511

  • Juntendo University

    Tokyo

Other trials in Japan

South Korea3 sites

  • National Cancer Center

    Goyang-si

  • Seoul National University Bundang Hospital

    Gyeonggi-do

  • Samsung Medical Center

    Seoul

Other trials in South Korea

Australia1 site

  • Epworth Healthcare

    East Melbourne, Australia, 9084

Other trials in Australia

China1 site

  • Chinese University of Hong Kong

    Hong Kong

Other trials in China

Taiwan1 site

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 Multi-Institution Randomized Prospective Clinical Trial Evaluating the Impact of Cytoreductive Radical Prostatectomy Combined With Best Systemic Therapy on Oncologic and Quality of Life Outcomes in Men With Newly Diagnosed Metastatic Prostate Cancer

This is a phase 2.5 international, multi-institution, randomized clinical trial to evaluate the potential therapeutic effect of CRP combined with the BST in men with mPCa prospectively. Such hybrid design permits the inclusion of the patients who have accrued to the phase 2 investigation to phase 3 trial, thereby decreasing the number of patients needed overall (5-7). In the initial phase 2 study, we plan to accrue 190 patients.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the clinical benefit of combining radical surgery - cytoreductive radical prostatectomy (CRP) - with the best systemic therapy (BST) - to be determined by the treating physician in men with newly diagnosed clinical mPCa.

SECONDARY OBJECTIVES:

  1. To determine the impact of CRP+BST on time to biochemical progression, cancer-specific survival, overall survival, complication rates, and quality of life (QOL) in patients with mPCa.

II. To determine the transcription levels of bone morphogenetic protein -6 (BMP-6) and transforming growth factor-beta (TGF-?).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (Control Group): BST - to be determined by the treating physician (ADT +/- docetaxel at the discretion of the treating physician).

ARM II: CRP + BST

Being tested
Antiandrogen Therapy, Docetaxel, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antiandrogen TherapyDrug

    Also called ADT, Androgen Deprivation Therapy, Anti-androgen Therapy, Anti-androgen Treatment

    To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.

  • DocetaxelDrug

    Also called Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

    To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Quality-of-Life AssessmentProcedure or surgery

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radical ProstatectomyProcedure or surgery

    Also called Prostatovesiculectomy

    Undergo cytoreductive radical prostatectomy

Study groups in NCT03456843
Study groupRoleWhat they receive
Arm I (Control Group)ExperimentalBST - to be determined by the treating physician. Currently, BST is permanent ADT +/- docetaxel (1-3). In patients who were treated with ADT ≥ 1 month prior to randomization, docetaxel, if chosen by the provided, will be given as soon as feasible. In men not treated with ADT or for a duration less than or equal to one month prior to randomization, ADT will be given for a minimum of one month prior to docetaxel therapy. All forms of ADT are allowed. The regimen will be at the discretion of the treating physician. Docetaxel regimen will be at the discretion of the provider. At the time of disease progression, the patient will come off the study treatment phase and enter into follow up. The next line of therapy will be at the discretion of the provider.
Receives: Drug: Antiandrogen Therapy; Drug: Docetaxel; Other: Laboratory Biomarker Analysis; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (Experimental)ExperimentalCRP+BST. Patients will undergo surgery if the duration of ADT is greater than one month prior to surgery. In men who have not been treated with ADT or received ADT less than or equal to one month prior to entering the study, ADT will be initiated or continued to ensure that the patients have been treated with ADT for at least one month prior to CRP. Docetaxel must be administered, if selected, prior to surgery. Following surgery, ADT will be continued. Although the surgical approach is at the discretion of the surgeon, robot assistance is the preferred primary approach. At the time of disease progression, the patient will come off the study treatment phase and enter into follow up. The next line of therapy will be at the discretion of the provider.
Receives: Drug: Antiandrogen Therapy; Drug: Docetaxel; Other: Laboratory Biomarker Analysis; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Radical Prostatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Failure-free survival (FFS)

    Failure is defined as any one of the following events: PSA progression, clinical progression, radiographic progression, or death. The % of men who fail within 2 years of randomization will be compare between the two groups using a one-sided log-rank test.

    Measured: At 2 years

Secondary outcomes (4)

  1. Cancer-specific survival

    Measured: Up to 2 years

  2. Overall complication rate

    Measured: Up to 2 years

  3. Time to biochemical progression

    Measured: Up to 2 years

  4. Overall survival

    Measured: Through study completion, a minimum of 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2018
  2. Study start20 Mar 2018
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03456843
Sponsor's protocol ID
2000031290
Other IDs
NCI-2018-00047, 081707, P30CA072720, Pro20170001506
Status last verified
Jul 2026
First submitted
20 Feb 2018
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Antiandrogen Therapy, Docetaxel and Laboratory Biomarker Analysis in people with Stage IV Prostate Adenocarcinoma AJCC v7, run by Yale University at 16 sites in 6 countries.

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 13 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Japan, South Korea, Australia, China and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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?

Failure-free survival (FFS) (time frame: At 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03456843.

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 24 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in