Prostate CancerPhase 3NCT00116142

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

A Phase 3 study testing Docetaxel, Androgen Hormonal Suppression and Radiation and Androgen Suppression Therapy and Radiation Therapy in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 30 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Docetaxel, Androgen Hormonal Suppression and Radiation and Androgen Suppression Therapy and Radiation Therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 350 participants
Where: 1 siteUnited States
Study dates: Jun 2005to 29 Jun 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Show all 9Show fewer

ECOG performance Status 0 or 1
Peripheral neuropathy must be =< grade 1
PSA obtained within 3 months of entry

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dana-Farber Cancer Institute and (Sanofi-Aventis Consortium)
Boston, Massachusetts, 02115

Other trials in United States

About this study

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

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.

Read the 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).

Conditions: Prostate Cancer
Being tested: Docetaxel, Androgen Hormonal Suppression and Radiation, Androgen Suppression Therapy and Radiation Therapy
Keywords: Prostate Cancer, Hormone Refractory, Metastatic, Localized, Locally Advanced, Prostate Cancer - High Risk Localized or Locally Advanced
Medical subject headings: Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DocetaxelDrug
Also called Taxotere
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.
Androgen Hormonal Suppression and RadiationDrug
Total Androgen Ablation and external beam radiation therapy
Androgen Suppression Therapy and Radiation TherapyDrug
Total Androgen Ablation and External Beam Radiation Therapy

Study groups in NCT00116142
Study group	Role	What they receive
Arm1: Androgen Suppression Therapy + Radiation Therapy	Other	Androgen Suppression Therapy and Radiation therapy Receives: 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 Receives: Drug: Docetaxel; Drug: Androgen Hormonal Suppression and Radiation; Drug: Androgen Suppression Therapy and Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Late adverse events will be focused on GU/GI including Urinary/Fecal Incontinence, Hematuria, Diarrhea, Rectal Bleeding and other.
Measured: Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 200529 Jun 2020

First posted28 Jun 2005 (estimated)
Study startJun 2005
Primary completion29 Jun 2020
Study completion29 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 350 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00116142
Sponsor's protocol ID: 05-043
Status last verified: Jan 2022
First submitted: 27 Jun 2005
Last updated: 11 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 38691823
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.
PubMed 37801315
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.
PubMed 34197181
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.
PubMed 24423462

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00116142
Acronym / sponsor ID: 05-043
Conditions: Prostate Cancer
Keywords: Prostate Cancer, Hormone Refractory, Metastatic, Localized, Locally Advanced, Prostate Cancer - High Risk Localized or Locally Advanced
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 350 participants (actual)
Lead sponsor: Dana-Farber Cancer InstituteUniversity, hospital or other
Collaborators: Sanofi
Study start: Jun 2005
Primary completion: 29 Jun 2020 (actual)
Study completion: 29 Jun 2020 (actual)
First posted: 28 Jun 2005 (estimated)
Results: Posted 28 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm1: Androgen Suppression Therapy + Radiation Therapy	Other	Drug: Androgen Hormonal Suppression and Radiation, Drug: Androgen Suppression Therapy and Radiation TherapyAndrogen Suppression Therapy and Radiation therapy
Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy	Experimental	Drug: Docetaxel, Drug: Androgen Hormonal Suppression and Radiation, Drug: Androgen Suppression Therapy and Radiation TherapyDocetaxel plus androgen suppression therapy and radiation therapy

Who may qualify

Ages: 30 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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)

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DocetaxelAlso: Taxotere60 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.	Drug	Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Androgen Hormonal Suppression and RadiationTotal Androgen Ablation and external beam radiation therapy	Drug	Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy, Arm1: Androgen Suppression Therapy + Radiation Therapy
Androgen Suppression Therapy and Radiation TherapyTotal Androgen Ablation and External Beam Radiation Therapy	Drug	Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy, Arm1: Androgen Suppression Therapy + Radiation Therapy

Primary outcome

10-Year Restricted Mean Survival Time for Overall Survival
Time frame: Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.
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

4 secondary outcomes

10-year Biochemical Recurrence (PSA Failure)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomization

Results and safety

Results posted to the registry on 28 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm1: Androgen Suppression Therapy + Radiation Therapy	175	156
Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy	175	155

Primary outcome: 10-Year Restricted Mean Survival Time for Overall Survival

Time frame: Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.. Mean (Standard Error). Unit: years

Measure	Arm1: Androgen Suppression Therapy + Radiation Therapy n = 175	Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy n = 175
Value	8.82 (0.19)	9.11 (0.15)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 13.9 years from randomization.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm1: Androgen Suppression Therapy + Radiation Therapy	63 of 174 (36.2%)	128 of 174 (73.6%)	45 of 175
Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy	87 of 171 (50.9%)	142 of 171 (83%)	44 of 175

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38691823Sayan 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.
Derived from this study: PubMed 37801315Sayan 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.
Derived from this study: PubMed 34197181D'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.
Derived from this study: PubMed 24423462Guttilla 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anthony V. D'Amico, MD, PhD principal investigator

Dana-Farber Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

10-Year Restricted Mean Survival Time for Overall Survival (time frame: Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00116142, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.