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

NCT00116142 | Completed Phase 3 Results DMC

• 1 other identifier: 05-043
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Hormone Refractory; Metastatic; Localized; Locally Advanced; Prostate Cancer - High Risk Localized or Locally Advanced

Outcome Measures

Primary Outcomes (1)

• 10-Year Restricted Mean Survival Time for Overall Survival

  Overall survival (OS) was measured from the date of random assignment to death from any cause, censored at the date of last follow-up in surviving patients. The 10-Year Restricted Mean Survival Time was calculated as the area under the Kaplan Meier plot for OS, from randomization to 10-years follow-up

  Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.

Secondary Outcomes (4)

• 10-year Biochemical Recurrence (PSA Failure)

  PSA was measured following the end of RT, then every 6 months for 5 years and annually thereafter, 10 years

• 10-year Prostate Cancer Mortality

  Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.

• Number of Participants With Acute Adverse Events

  During study treatment or within 30 days of the last dose of study, up to 7.2 months from randomization

• Number of Participants With Late Adverse Events, Any Grade and Attribution

  Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomization

Study Arms (2)

Arm1: Androgen Suppression Therapy + Radiation Therapy

OTHER

Androgen Suppression Therapy and Radiation therapy

Drug: Androgen Hormonal Suppression and Radiation; Drug: Androgen Suppression Therapy and Radiation Therapy

Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy

EXPERIMENTAL

Docetaxel plus androgen suppression therapy and radiation therapy

Drug: Docetaxel; Drug: Androgen Hormonal Suppression and Radiation; Drug: Androgen Suppression Therapy and Radiation Therapy

Interventions

Docetaxel DRUG

60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.

Also known as: Taxotere

Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy

Androgen Hormonal Suppression and Radiation DRUG

Total Androgen Ablation and external beam radiation therapy

Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy; Arm1: Androgen Suppression Therapy + Radiation Therapy

Androgen Suppression Therapy and Radiation Therapy DRUG

Total Androgen Ablation and External Beam Radiation Therapy

Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy; Arm1: Androgen Suppression Therapy + Radiation Therapy

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Sanofi: collaborator

Study Sites (1)

Dana-Farber Cancer Institute and (Sanofi-Aventis Consortium)

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• Sayan M, Chen MH, Loffredo M, McMahon E, Moningi S, Orio PF, Nguyen PL, D'Amico AV. Elective Pelvic Lymph Node Radiation Therapy and the Risk of Death in Patients With Unfavorable-Risk Prostate Cancer: A Postrandomization Analysis. J Clin Oncol. 2024 Jul 20;42(21):2558-2564. doi: 10.1200/JCO.23.02394. Epub 2024 May 1.

  PMID: 38691823 DERIVED

• Sayan M, Huang J, Xie W, Chen MH, Loffredo M, McMahon E, Orio P, Nguyen P, D'Amico AV. Risk of Short-Term Prostate-Specific Antigen Recurrence and Failure in Patients With Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2336390. doi: 10.1001/jamanetworkopen.2023.36390.

  PMID: 37801315 DERIVED

• 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.

  PMID: 34197181 DERIVED

• 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.

  PMID: 24423462 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Docetaxel; Radiation; 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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Physical Phenomena; Therapeutics

Results Point of Contact

• Title: Anthony D'Amico
• Organization: Dana Farber Cancer Institute

ADAMICO@LROC.HARVARD.EDU

617.732.6310

Study Officials

• Anthony V. D'Amico, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2005
• First Posted: June 28, 2005
• Study Start: June 1, 2005
• Primary Completion: June 29, 2020
• Study Completion: June 29, 2020
• Last Updated: January 11, 2022
• Results First Posted: July 28, 2021

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)