Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer

NCT00348816 | Terminated Phase 2 Results

• 2 other identifiers: CDR0000486733HSC20050377H.
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy and prednisone after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy and prednisone works in treating patients who have undergone surgery for prostate cancer.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.

  Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero..

  5 years

Secondary Outcomes (3)

• Progression-free Survival Based on PSA Progression

  5 years

• Overall Survival

  5 years

• Correlation Between Velocity of Subsequent PSA Failure and Survival

  5 years

Study Arms (1)

Docetaxel (Single Arm)

EXPERIMENTAL

Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Prednisone 5mg twice a day Radical prostatectomy as standard of care Radiation therapy will be used as standard of care Post radiation Doxcetaxel

Drug: docetaxel; Drug: prednisone; Procedure: Radical prostatectomy; Radiation: Radiation therapy

Interventions

docetaxel DRUG

Docetaxel 20mg/m2/week IV every week during standard of care radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.

Also known as: Taxotere

Docetaxel (Single Arm)

prednisone DRUG

Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.

Also known as: prednisone oral

Docetaxel (Single Arm)

Radical prostatectomy PROCEDURE

Radical prostatectomy as part of standard care

Docetaxel (Single Arm)

Radiation therapy RADIATION

Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.

Docetaxel (Single Arm)

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed prostate cancer
• Prostate-specific antigen (PSA) level \> 0.2 ng/mL after radical prostatectomy performed ≥ 6 weeks ago
• No lymph node-positive prostate cancer
• No documented metastatic disease
• CT scan of the abdomen and pelvis negative (within the past 6 months)
• No bone pain OR negative bone scan (within the past 6 months)
• ECOG performance status 0-2
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Bilirubin normal
• ALT and AST ≤ 1.5 times upper limit of normal
• Alkaline phosphatase normal
• Fertile patients must use effective contraception
• No peripheral neuropathy \> grade 1

You may not qualify if:

• No prior orchiectomy
• No prior chemotherapy regimen for this disease
• No prior pelvic radiotherapy
• No pre- or postoperative androgen manipulation, such as luteinizing hormone-releasing hormone agonists, antiandrogens (flutamide, bicalutamide, or nilutamide), or finasteride
• Preoperative androgen manipulation for a duration of ≤ 3 months allowed
• No prior immunotherapy
• No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other systemic radioisotopes
• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
• No concurrent herbal or alternative regimens including, but not limited to, any of the following:
• Saw palmetto
• PC-SPES
• Shark cartilage
• No other concurrent investigational agents
• No other concurrent chemotherapy, immunotherapy, or hormonal therapy (except for replacement steroids)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Prednisone; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Therapeutics

Results Point of Contact

• Title: Gregory P. Swanson, MD
• Organization: The University of Texas Health Science Center at San Antonio, Department of Radiation Oncology

swansong@uthscsa.edu

210-450-1103

Study Officials

• Gregory P. Swanson, MD

  The University of Texas Health Science Center at San Antonio

  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: July 5, 2006
• First Posted: July 6, 2006
• Study Start: May 1, 2006
• Primary Completion: July 8, 2016
• Study Completion: July 8, 2016
• Last Updated: December 8, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-04

Locations

US (1)