NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer

CompletedPhase 3

Sponsor: Dana-Farber Cancer Institute

Conditions: Prostate Cancer

Interventions: Docetaxel, Androgen Hormonal Suppression and Radiation, Androgen Suppression Therapy and Radiation Therapy

Countries: United States

This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer.

Eligibility overview

Sex: MALE

Age: 30 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Biopsy proven prostate cancer
* Clinical Tumor Category T1b, T1c, T2a and PSA greater than (\>) 10 or Gleason score equal or greater than 4+3=7 or PSA velocity \> 2.0 ng/ml per year and also eligible patients with tumor category T2c, T3a, T3b, or T4 as per 2002 AJCC guidelines. Any minor tertiary grade of Gleason 5; Biopsy Proven or Radiographic (erMRI Seminal Vesicle Invasion); Gleason = or \> 3+4=7 with 50% or more cores positive
* Negative bone scan
* Lymph node assessment by CT or MR
* Adequate hematologic function (Blood Counts)
* Adequate liver functions (blood tests)
* ECOG performance Status 0 or 1
* Peripheral neuropathy must be =\< grade 1
* PSA obtained within 3 months of entry

Exclusion Criteria:

* Prior history of malignancy that are \< 5 years except for cancers found to be "in-situ" and would not likely impact a patient's life expectancy with appropriate medical management.
* Prior pelvic radiation therapy
* Prior hormonal therapy (up to 4 weeks prior to enrollment allowed)
* Individuals unable to tolerate lying still 5 - 10 minutes
* Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 90.

Locations (1)

Boston, Massachusetts, United States