Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic Prostate Cancer

NCT00669162 | Completed Phase 1 Results DMC

• 1 other identifier: 12313
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Following a radical prostatectomy and lymph node sampling, eligible patients will undergo post-operative radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3 months for 2 times).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Can Safely Tolerate and Complete Adjuvant Hormonal Therapy, Radiation Therapy and Docetaxel After a Radical Prostatectomy

  Defined as percentage of patients that complete full dose of Radiation Therapy (RT)

  8 Months

Study Arms (1)

RT, Docetaxel, Hormonal Therapy

EXPERIMENTAL

Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2)

Drug: Docetaxel; Radiation: Radiation Therapy; Drug: Casodex and Zoladex (or Lupron)

Interventions

Docetaxel DRUG

20mg/m2 IV weekly for 7 weeks

Also known as: Taxotere

RT, Docetaxel, Hormonal Therapy

Radiation Therapy RADIATION

66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx

RT, Docetaxel, Hormonal Therapy

Casodex and Zoladex (or Lupron) DRUG

Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2)

Also known as: Bicalutaminde, Leuprolide

RT, Docetaxel, Hormonal Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Histologically documented adenocarcinoma of the prostate.
• Status post radical prostatectomy with sampling of the pelvic lymph nodes with histologically confirmed adenocarcinoma of the prostate, with the patients falling into either the "adjuvant high risk group" or the "salvage high risk group" as follows:
• a) "Adjuvant High Risk Group" (undetectable, persistent or decreasing PSA levels before starting therapy) who have NO evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence) who MUST be able to start RT treatments within 6 months of radical prostatectomy with at least one of the 3 disease features:
• Pathologic tumor 2-node 0 (T2N0) disease with positive margins and Gleason score ≥8, or
• Pathologic tumor 3a-node 0 T3aN0 disease with extracapsular extension and Gleason Score ≥ 8, or
• Pathologic tumor 3b-node 0 T3bN0 disease with any Gleason Score
• b) "Salvage High Risk Group" are those patients with PSA biochemical failure defined by 2 consecutive increases over baseline PSA levels at least one month apart, who have NO other evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence), and WITH AT LEAST ONE of the high risk disease features as defined below:
• Pathologic T3bN0 disease with any Gleason score, or
• Pathologic T2-3aN0 disease with Gleason score ≥ 8,
• Pathologic T2-3aN0 disease with PSA doubling time ≤10 months, or
• Pathologic T2-3aN0 disease with Pre-radiation therapy PSA level ≥1.0 ng/ml
• Neoadjuvant hormonal therapy prior to radical prostatectomy is allowed, and post-prostatectomy hormonal therapy is allowed as long as it is not within 6 months of protocol treatment
• No prior chemotherapy, or pelvic irradiation
• Karnofsky Performance Status ≥70
• Hematologic parameters must be within the following limits:

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Radiotherapy; bicalutamide; Goserelin; Leuprolide

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; Therapeutics; 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

Results Point of Contact

• Title: Xinglei Shen, MD
• Organization: University of Kansas Cancer Center

ctnursenav@kumc.edu

913-588-3600

Study Officials

• Xinglei Shen, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 29, 2008
• Study Start: August 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: April 1, 2017
• Last Updated: July 24, 2019
• Results First Posted: July 24, 2019

Record last verified: 2018-02

Locations

US (1)