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

PHASE2RECRUITING

This randomized phase II trial studies how well surgical removal of the prostate and antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen therapy may lessen the amount of androgens made by the body.

Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Surgery, antiandrogen therapy and docetaxel may work better in treating participants with prostate cancer.

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Study details:

PRIMARY OBJECTIVES:. I. To assess the clinical benefit of combining radical surgery cytoreductive radical prostatectomy (CRP) - with the best systemic therapy (BST) in men with newly diagnosed clinical metastatic prostate cancer (mPCa).

SECONDARY OBJECTIVES:. I. To determine the impact of CRP+BST on time to biochemical progression, cancer-specific 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: Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician. ARM II: Participants receive antiandrogen therapy for at least 1 month, then undergo cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may receive docetaxel prior to surgery at the discretion of the treating physician.

After completion of study treatment, patients are followed up every 6 months from time of progression.

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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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: Male

Things to know

Study dates

Study start: 2018-03-14

Primary completion: 2024-10-31

Study completion finish: 2024-10-31

Study type

TREATMENT

Phase

PHASE2

Trial 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

Image related to Stage IV Prostate Adenocarcinoma AJCC v7

Condition: Stage IV Prostate Adenocarcinoma AJCC v7
DRUG: Antiandrogen Therapy and other drugs
East Melbourne, Not Specified, Australia
Sponsor: Yale University

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Epworth Healthcare

Research sites nearby

Select from list below to view details:

Epworth Healthcare
East Melbourne, Not Specified, Australia

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 (ADT, docetaxel) Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.	DRUG: Antiandrogen Therapy 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.
EXPERIMENTAL: Arm II (ADT, radical prostatectomy, docetaxel) Participants receive antiandrogen therapy for at least 1 month, then undergo cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may receive docetaxel prior to surgery at the discretion of the treating physician.	DRUG: Antiandrogen Therapy 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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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