Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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

PHASE2ACTIVE_NOT_RECRUITING

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.

Study details:

PRIMARY OBJECTIVES:. I. 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:. I. 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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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 antiandrogen therapy (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

Exclusion criteria

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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE2

Study ID

NCT03456843

Intervention or treatment

DRUG: Antiandrogen Therapy

DRUG: Docetaxel

OTHER: Laboratory Biomarker Analysis

PROCEDURE: Quality-of-Life Assessment

OTHER: Questionnaire Administration

PROCEDURE: Radical Prostatectomy

Conditions

Stage IV Prostate Adenocarcinoma AJCC v7

Condition: Stage IV Prostate Adenocarcinoma AJCC v7
DRUG: Antiandrogen Therapy and other drugs
East Melbourne, Australia
Sponsor: Yale University

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Research sites nearby

Closest Location:

Epworth Healthcare

Select from list below to view details:

Epworth Healthcare
East Melbourne, Australia

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Who is running the clinical trial?

Yale University

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm I (Control Group) 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
EXPERIMENTAL: Arm II (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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm I (Control Group)

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

EXPERIMENTAL: Arm II (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

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
Failure-free survival (FFS)	Failure is defined as any one of the following events: PSA progression, clinical progression, radiographic progression, or death from prostate cancer. 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 Outcome

Measure	Description	Time Frame
Cancer-specific survival	Not Specified	Up to 2 years
Overall complication rate	Not Specified	Up to 2 years
Time to biochemical progression	Not Specified	Up to 2 years
Overall survival	Not Specified	Through study completion, a minimum of 4 years

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References

Clinical Trials Gov: Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer

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