Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer

NCT01076335 | Completed Phase 2 Results

• 3 other identifiers: 2004-0273P50CA090270NCI-2010-01369
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Year

Study Arms (1)

Neoadjuvant Hormones + Docetaxel

EXPERIMENTAL

Neoadjuvant Hormonal Therapy plus Docetaxel followed by Radical Prostatectomy

Drug: Neoadjuvant Hormonal Therapy; Drug: Docetaxel

Interventions

Neoadjuvant Hormonal Therapy DRUG

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

Also known as: Leuprolide Acetate, Goserelin Acetate

Neoadjuvant Hormones + Docetaxel

Docetaxel DRUG

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

Also known as: Taxotere

Neoadjuvant Hormones + Docetaxel

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77007, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms; Lymphatic Metastasis

Interventions

Leuprolide; Goserelin; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Lance Pagliaro, MD
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

1-877-632-6789

Study Officials

• Lance Pagliaro, MD, BA

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Study Start: May 1, 2005
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 19, 2016
• Results First Posted: August 8, 2016

Record last verified: 2016-08

Locations

US (1)