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Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer

S

SCRI Development Innovations

Status and phase

Completed
Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Docetaxel
Drug: Estramustine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00193271
IIT16165
SCRI GU 19

Details and patient eligibility

About

This trial will evaluate the feasibility, toxicity, and efficacy of docetaxel/estramustine, as in the adjuvant therapy of patients with high-risk prostate cancer after definitive local therapy.

Full description

Upon determination of eligibility, patients will receive:

Docetaxel + Estramustine

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

To be included in this study, you must meet the following criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Clinically or surgically staged localized disease, stage I-III.
  • Prior surgical resection or radiation therapy with curative intent
  • No clinical evidence of residual disease
  • Gleason's combined score > 7.
  • Age > 18 years.
  • No prior chemotherapy for prostate cancer.
  • No previous androgen deprivation therapy for prostate cancer
  • Able to perform activities of daily living with minimal assistance
  • Adequate bone marrow, liver and kidney function
  • Voluntarily provide written informed consent.

Exclusion criteria

You cannot participate in this study if any of the following apply to you:

  • History of prior malignancy in the past five years
  • History of significant heart disease within the previous 6 months
  • Cerebral vascular accident (CVA) or stroke within the previous 6 months.
  • Moderate or severe peripheral neuropathy
  • Previous therapy with other injectable radioisotopes.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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