Clinical trial NCT00116142: Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer
Official title: Docetaxel Plus 6-month Androgen Suppression and Radiation Therapy Versus 6-month Androgen Suppression and Radiation Therapy for Patients With High Risk Localized or Locally Advanced Prostate Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Hormone Refractory
Metastatic
Localized
Locally Advanced
Prostate Cancer - High Risk Localized or Locally Advanced
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-06-28
Enrollment: 350
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Radiation therapy plus six months of hormone therapy is one standard way of treating men with high-risk prostate cancer. In this study, we want to see whether or not adding the chemotherapy drug docetaxel (Taxotere)will make this treatment more effective. Docetaxel has shown a benefit in median survival when given to men who have become resistant to hormonal therapy and in men who have metastatic prostate cancer (spread to other areas of the body).

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.

Primary outcomes:
measure: 10-Year Restricted Mean Survival Time for Overall Survival
timeFrame: Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.
Secondary outcomes:
measure: 10-year Biochemical Recurrence (PSA Failure)
timeFrame: PSA was measured following the end of RT, then every 6 months for 5 years and annually thereafter, 10 years
measure: 10-year Prostate Cancer Mortality
timeFrame: Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.
measure: Number of Participants With Acute Adverse Events
timeFrame: During study treatment or within 30 days of the last dose of study, up to 7.2 months from randomization
measure: Number of Participants With Late Adverse Events, Any Grade and Attribution
timeFrame: Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute and (Sanofi-Aventis Consortium)
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Anthony V. D'Amico, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Amico AV, Xie W, McMahon E, Loffredo M, Medeiros S, Joseph D, Denham J, Kumar P, Bubley G, Sullivan M, Hellwig R, Carlos Vera J, Freter R, Jeffrey Baker W, Wong JY, Renshaw AA, Kantoff PW. Radiation and Androgen Deprivation Therapy With or Without Docetaxel in the Management of Nonmetastatic Unfavorable-Risk Prostate Cancer: A Prospective Randomized Trial. J Clin Oncol. 2021 Sep 10;39(26):2938-2947. doi: 10.1200/JCO.21.00596. Epub 2021 Jul 1.
citation: Guttilla A, Bortolus R, Giannarini G, Ghadjar P, Zattoni F, Gnech M, Palumbo V, Valent F, Garbeglio A, Zattoni F. Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial. Radiat Oncol. 2014 Jan 14;9:24. doi: 10.1186/1748-717X-9-24.