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

NCT03456843 | Active Not Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: 2000031290NCI-2018-00047081707P30CA072720Pro20170001506
• Study Type: interventional
• Target: 190
• Locations: 6 countries
• Sites: 16

Brief 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. 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.

Conditions

Stage IV Prostate Adenocarcinoma AJCC v7

Outcome Measures

Primary Outcomes (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.

  At 2 years

Secondary Outcomes (4)

• Cancer-specific survival

  Up to 2 years

• Overall complication rate

  Up to 2 years

• Time to biochemical progression

  Up to 2 years

• Overall survival

  Through study completion, a minimum of 4 years

Study Arms (2)

Arm I (Control Group)

EXPERIMENTAL

BST - 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.

Drug: Antiandrogen Therapy; Drug: Docetaxel; Other: Laboratory Biomarker Analysis; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (Experimental)

EXPERIMENTAL

CRP+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.

Drug: Antiandrogen Therapy; Drug: Docetaxel; Other: Laboratory Biomarker Analysis; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Radical Prostatectomy

Interventions

Docetaxel DRUG

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.

Also known as: Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

Arm I (Control Group); Arm II (Experimental)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (Control Group); Arm II (Experimental)

Quality-of-Life Assessment PROCEDURE

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (Control Group); Arm II (Experimental)

Questionnaire Administration OTHER

Ancillary studies

Arm I (Control Group); Arm II (Experimental)

Radical Prostatectomy PROCEDURE

Undergo cytoreductive radical prostatectomy

Also known as: Prostatovesiculectomy

Arm II (Experimental)

Antiandrogen Therapy DRUG

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.

Also known as: ADT, Androgen Deprivation Therapy, Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy

Arm I (Control Group); Arm II (Experimental)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (16)

City of Hope

Duarte, California, 91010, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Swedish Medical Services

Seattle, Washington, 98104, United States

Location

Epworth Healthcare

East Melbourne, Australia, 9084, Australia

Location

Chinese University of Hong Kong

Hong Kong, China

Location

Kindai University

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

Akita University

Akita, Japan

Location

Juntendo University

Tokyo, Japan

Location

National Cancer Center

Goyang-si, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Androgen Antagonists; Docetaxel

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Isaac Kim, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 7, 2018
• Study Start: March 20, 2018
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

CN (1); JP (3); US (7); AU (1); TW (1); KR (3)