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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Docetaxel

Androgen Hormonal Suppression and Radiation

Androgen Suppression Therapy and Radiation Therapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Hormone Refractory, Metastatic, Localized, Locally Advanced, Prostate Cancer - High Risk Localized or Locally Advanced

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Arm1: Androgen Suppression Therapy + Radiation Therapy

Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy

Arm Description

Androgen Suppression Therapy and Radiation therapy

Docetaxel plus androgen suppression therapy and radiation therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

10-year Biochemical Recurrence (PSA Failure)

Time to biochemical recurrence was defined as the time from date of random assignment to the earliest of PSA failure or initiation of salvage therapy, or censored at the date of last disease assessment for those without PSA failure. PSA failure was defined according to the 2006 RTOG-ASTRO Phoenix definition (i.e., A PSA rise by 2 ng/mL or more above the nadir). 10-year biochemical recurrence rate was estimated from a competing risk model where non-prostate cancer death was counted as competing risk.

10-year Prostate Cancer Mortality

Measured from the date of random assignment to date of death from prostate cancer, or censored at the date of last follow-up in surviving patients. Patients who died due to other reasons were counted as competing risk in a competing risk model.

Number of Participants With Acute Adverse Events

Adverse acute events were reported via the clinical database only for toxicities considered reportable via the SAE mechanism (those of grade 2 and grade 3 events that are unexpected and possibly, probably, or definitely related/associated with treatment; or all grade 4 and grade 5 events). Common Toxicity Criteria Volume 3.0 (CTCAE) is used for this study.

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

Late adverse events will be focused on GU/GI including Urinary/Fecal Incontinence, Hematuria, Diarrhea, Rectal Bleeding and other.

Full Information

NCT ID

NCT00116142

First Posted

June 27, 2005

Last Updated

January 6, 2022

Sponsor

Dana-Farber Cancer Institute

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00116142

Brief Title

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

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

June 29, 2020 (Actual)

Study Completion Date

June 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

350 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm1: Androgen Suppression Therapy + Radiation Therapy

Arm Type

Other

Arm Description

Androgen Suppression Therapy and Radiation therapy

Arm Title

Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy

Arm Type

Experimental

Arm Description

Docetaxel plus androgen suppression therapy and radiation therapy

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Androgen Hormonal Suppression and Radiation

Intervention Description

Total Androgen Ablation and external beam radiation therapy

Intervention Type

Drug

Intervention Name(s)

Androgen Suppression Therapy and Radiation Therapy

Intervention Description

Total Androgen Ablation and External Beam Radiation Therapy

Primary Outcome Measure Information:

Title

10-Year Restricted Mean Survival Time for Overall Survival

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

10-year Biochemical Recurrence (PSA Failure)

Description

Time to biochemical recurrence was defined as the time from date of random assignment to the earliest of PSA failure or initiation of salvage therapy, or censored at the date of last disease assessment for those without PSA failure. PSA failure was defined according to the 2006 RTOG-ASTRO Phoenix definition (i.e., A PSA rise by 2 ng/mL or more above the nadir). 10-year biochemical recurrence rate was estimated from a competing risk model where non-prostate cancer death was counted as competing risk.

Time Frame

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

Title

10-year Prostate Cancer Mortality

Description

Measured from the date of random assignment to date of death from prostate cancer, or censored at the date of last follow-up in surviving patients. Patients who died due to other reasons were counted as competing risk in a competing risk model.

Time Frame

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

Title

Number of Participants With Acute Adverse Events

Description

Adverse acute events were reported via the clinical database only for toxicities considered reportable via the SAE mechanism (those of grade 2 and grade 3 events that are unexpected and possibly, probably, or definitely related/associated with treatment; or all grade 4 and grade 5 events). Common Toxicity Criteria Volume 3.0 (CTCAE) is used for this study.

Time Frame

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

Title

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

Description

Late adverse events will be focused on GU/GI including Urinary/Fecal Incontinence, Hematuria, Diarrhea, Rectal Bleeding and other.

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony V. D'Amico, MD, PhD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

34197181

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.

Results Reference

derived

PubMed Identifier

24423462

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.

Results Reference

derived

Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial