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Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Neoadjuvant Hormonal Therapy

Docetaxel

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Neoadjuvant Hormonal Therapy, Docetaxel, Taxotere, Chemotherapy, Radical Prostatectomy, Node-positive Prostate Cancer, Androgen-dependent prostate cancer, Lymph node metastases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients with adenocarcinoma of the prostate that in the opinion of the surgeon could be resectable after response to systemic therapy. Ductal carcinoma variant is included.
All patients must be regarded as acceptable anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy.
Zubrod performance status 2 or better.
All patients must have thorough tumor staging and meet one of the following criteria: a) Either lymph node biopsy or lymph node dissection demonstrating presence of lymph node metastasis. b) Pelvic or retroperitoneal lymphadenopathy >/= 2.0 cm visualized on CT scan (biopsy is not required if >/= 2.0 cm and in typical distribution) c) Primary tumor Gleason score >/= 8 and serum PSA concentration >/= 25 ng/ml, indicating high risk of occult lymph node metastases.
(# 4 cont'd) d) Primary tumor stage T3 and Gleason score >/= 7, indicating high risk of occult lymph node metastases. e) Primary tumor stage T4 indicating high risk of occult lymph node metastases.
Prior hormonal therapy up to 6 months is permitted. No concurrent ketoconazole is permitted.
Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of > 1,500/mm^3 and platelet count of > 100,000/mm^3; adequate hepatic function defined with a total bilirubin of < 1.5 mg/dl and AST/ALT < 2X the upper limits of normal; adequate renal function defined as serum creatinine clearance > 40 cc/min (measured or calculated).
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
All patients must be evaluated in the Department of Urology and Department of Genitourinary Medical Oncology prior to signing informed consent.

Exclusion Criteria:

Patients with small cell or sarcomatoid histology.
Patients with clinical or radiological evidence of bone or other extranodal metastasis (M1b or M1c).
Prior chemotherapy.
Patients with severe or uncontrolled intercurrent infection.
Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina or history of myocardial infarction within the last 6 months.
Contraindications to corticosteroids.
Uncontrolled severe hypertension, persistently uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease or HIV infection.
Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years.
Overt psychosis, mental disability or otherwise incompetent to give informed consent.

Sites / Locations

University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant Hormones + Docetaxel

Arm Description

Neoadjuvant Hormonal Therapy plus Docetaxel followed by Radical Prostatectomy

Outcomes

Primary Outcome Measures

Number of Participants Progression Free at 1 Year

Participants prostatic specific antigen (PSA) progression-free or event-free survival (that is, freedom from treatment failure) 1 year postoperatively. Treatment failure defined as objective tumor progression during therapy or in year after surgery, confirmed postoperative PSA ⩾1 ngml - 1, or any postoperative radiation, hormonal or other systemic therapy. Participants who did not undergo surgery within 8 weeks of completing 1 year of therapy on protocol (for any reason, including participant refusal) were counted as treatment failure, as were participants whose surgery was begun and aborted.

Secondary Outcome Measures

Full Information

NCT ID

NCT01076335

First Posted

February 24, 2010

Last Updated

August 8, 2016

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01076335

Brief Title

Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer

Official Title

Phase II Study of Neoadjuvant Hormonal Therapy Plus Docetaxel Followed by Radical Prostatectomy for Men With Proven or Suspected Node-positive Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this clinical research study is to find out if a therapy using docetaxel chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to treatment of prostate cancer. The safety of this combination will also be studied.

Detailed Description

Advanced prostate cancer may be responsive to a combination of hormonal and chemotherapy treatments. Researchers believe that the use of chemotherapy and hormonal therapy before your scheduled surgery may help to affect or delay the progression of prostate cancer. Before surgery, you will have imaging studies, including a chest x-ray, CT scan and a bone scan. You may also have an MRI scan. These tests are being done to check on the status of the disease. You will also have 3 tablespoons of blood drawn for routine blood tests, before treatment. All treatment will be given on an outpatient basis. Treatment should start as soon as possible, within 14 days after registration. You will receive hormonal treatment once a month for the 12 months before your surgery. Hormonal treatments will not continue after the surgery. You will be given dexamethasone, Benadryl® (diphenylhydramine) and Pepcid® (famotidine) , by a vein in your arm or by central line in a vein before your therapy begins with docetaxel on Day 1 of the first treatment cycle. Dexamethasone will help decrease bone marrow inflammation. Diphenhydramine helps prevent allergic reactions. Famotidine protects you against stomach irritation by decreasing the amount of acid in your stomach. Docetaxel will be given through a needle in your vein (IV) once a week during the first 4 weeks of each 6-week period (called a study cycle). Each dose of docetaxel will take about an hour to be given. The total treatment time to complete the docetaxel will be 3 study cycles (18 weeks). Before each 6-week study cycle with docetaxel, you will come to the clinic for a physical exam and routine blood tests (2 tablespoons). After your treatment with docetaxel and hormones, you will then have an operation to remove the prostate gland and the tumor. Your doctor will discuss the surgical procedure with you in detail and explain the risks of the operation. You will need to sign a separate consent form before undergoing the surgical procedure. After surgery, you will be closely checked for any possible side effects. After completion of the treatment, you will be monitored every 3 months for the first year and every 6 months for the second year. You will also have 2 tablespoons of blood drawn for routine blood test monitoring at every follow-up visit. This is an investigational study. Docetaxel and the hormone treatments used in this study are FDA approved medications for the treatment of prostate cancer. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Neoadjuvant Hormonal Therapy, Docetaxel, Taxotere, Chemotherapy, Radical Prostatectomy, Node-positive Prostate Cancer, Androgen-dependent prostate cancer, Lymph node metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant Hormones + Docetaxel

Arm Type

Experimental

Arm Description

Neoadjuvant Hormonal Therapy plus Docetaxel followed by Radical Prostatectomy

Intervention Type

Drug

Intervention Name(s)

Neoadjuvant Hormonal Therapy

Other Intervention Name(s)

Leuprolide Acetate, Goserelin Acetate

Intervention Description

Monthly or quarterly LHRH Agonist Depot injection (leuprolide or goserelin acetate) for one year.

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

35 mg/m2 by vein (IV) on Day 1, 8, 15 and 22 every 6 weeks.

Primary Outcome Measure Information:

Title

Number of Participants Progression Free at 1 Year

Description

Time Frame

1 Year

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with adenocarcinoma of the prostate that in the opinion of the surgeon could be resectable after response to systemic therapy. Ductal carcinoma variant is included. All patients must be regarded as acceptable anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy. Zubrod performance status 2 or better. All patients must have thorough tumor staging and meet one of the following criteria: a) Either lymph node biopsy or lymph node dissection demonstrating presence of lymph node metastasis. b) Pelvic or retroperitoneal lymphadenopathy >/= 2.0 cm visualized on CT scan (biopsy is not required if >/= 2.0 cm and in typical distribution) c) Primary tumor Gleason score >/= 8 and serum PSA concentration >/= 25 ng/ml, indicating high risk of occult lymph node metastases. (# 4 cont'd) d) Primary tumor stage T3 and Gleason score >/= 7, indicating high risk of occult lymph node metastases. e) Primary tumor stage T4 indicating high risk of occult lymph node metastases. Prior hormonal therapy up to 6 months is permitted. No concurrent ketoconazole is permitted. Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of > 1,500/mm^3 and platelet count of > 100,000/mm^3; adequate hepatic function defined with a total bilirubin of < 1.5 mg/dl and AST/ALT < 2X the upper limits of normal; adequate renal function defined as serum creatinine clearance > 40 cc/min (measured or calculated). Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution. All patients must be evaluated in the Department of Urology and Department of Genitourinary Medical Oncology prior to signing informed consent. Exclusion Criteria: Patients with small cell or sarcomatoid histology. Patients with clinical or radiological evidence of bone or other extranodal metastasis (M1b or M1c). Prior chemotherapy. Patients with severe or uncontrolled intercurrent infection. Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina or history of myocardial infarction within the last 6 months. Contraindications to corticosteroids. Uncontrolled severe hypertension, persistently uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease or HIV infection. Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years. Overt psychosis, mental disability or otherwise incompetent to give informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lance Pagliaro, MD, BA

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77007

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer

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