Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer (CHAARTED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00309985

Recruitment Status : Active, not recruiting

First Posted : April 3, 2006

Results First Posted : March 3, 2016

Last Update Posted : March 18, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Metastatic Hormone-sensitive Prostate Cancer
Interventions	Drug: androgen-deprivation therapy Drug: docetaxel
Enrollment	790

Participant Flow

Recruitment Details	This study was activated on July 28, 2006, accrued its first patient on September 26, 2006, and closed to accrual on November 21, 2012, after accrual of 790 patients.
Pre-assignment Details


Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description	Patients receive androgen-deprivati...	Patients receive androgen-deprivati...
Arm/Group Description	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Period Title: Overall Study
Started	397	393
Toxicity Analysis	390	392
Both Baseline and 3-month FACT-P Evals	334	299
Completed	335	392 ^[1]
Not Completed	62	1
Reason Not Completed
Disease progression	12	0
Adverse Event	30	0
Death	2	0
Withdrawal by Subject	5	1
Physician Decision	3	0
Never started treatment	7	0
Complicating disease	1	0
Non-compliance	1	0
Chemotherapy discontinued only	1	0
[1] Arm B tx info was not collected so only 1 patient w/o follow-up data was considered "not completed".

Baseline Characteristics

Arm/Group Title		Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone	Total
Arm/Group Description		Patients receive androgen-deprivati...	Patients receive androgen-deprivati...	Total of all reporting groups
Arm/Group Description		Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).	Total of all reporting groups
Overall Number of Baseline Participants		397	393	790
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All randomized patients
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	397 participants	393 participants	790 participants
		64 (36 to 88)	63 (39 to 91)	63 (36 to 91)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	397 participants	393 participants	790 participants
	Female	0 0.0%	0 0.0%	0 0.0%
	Male	397 100.0%	393 100.0%	790 100.0%

Outcome Measures

1.Primary Outcome


Title	Overall Survival
Description	Overall survival is defined as the time from randomization to death or...
Description	Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.
Time Frame	Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Outcome Measure Data

Analysis Population Description

All randomized patients


Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description:	Patients receive androgen-deprivati...	Patients receive androgen-deprivati...
Arm/Group Description:	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Overall Number of Participants Analyzed	397	393
Median (95% Confidence Interval) Unit of Measure: months
	57.6 (49.1 to 72.8)	44.0 (34.4 to 49.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
	Comments	The study was designed to detect a 33.3% improvement in median survival time across treatments with one-sided type I error of 0.025 and 80% power.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0003
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

2.Secondary Outcome


Title	Time to Clinical Progression
Description	Time to clinical progression is defined as the time from randomization...
Description	Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Time Frame	Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Outcome Measure Data

Analysis Population Description

All randomized patients.


Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description:	Patients receive androgen-deprivati...	Patients receive androgen-deprivati...
Arm/Group Description:	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Overall Number of Participants Analyzed	397	393
Median (95% Confidence Interval) Unit of Measure: months
	33.0 (27.3 to 41.2)	19.8 (17.9 to 22.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

3.Secondary Outcome


Title	Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)
Description	Time to castration resistant prostate cancer is defined as the time fr...
Description	Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Time Frame	Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Outcome Measure Data

Analysis Population Description

All randomized patients.


Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description:	Patients receive androgen-deprivati...	Patients receive androgen-deprivati...
Arm/Group Description:	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Overall Number of Participants Analyzed	397	393
Median (95% Confidence Interval) Unit of Measure: months
	20.2 (17.2 to 23.6)	11.7 (10.8 to 14.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

4.Secondary Outcome


Title	Proportion of Patients With PSA Complete Response (CR) at 6 Months
Description	PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 co...
Description	PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.
Time Frame	Assessed at 6 months

Outcome Measure Data

Analysis Population Description

All randomized patients


Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description:	Patients receive androgen-deprivati...	Patients receive androgen-deprivati...
Arm/Group Description:	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Overall Number of Participants Analyzed	397	393
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: proportion of participants
	0.320 (0.274 to 0.369)	0.196 (0.158 to 0.239)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

5.Secondary Outcome


Title	Proportion of Patients With PSA Complete Response (CR) at 12 Months
Description	PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 co...
Description	PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.
Time Frame	Assessed at 12 months

Outcome Measure Data

Analysis Population Description

All randomized patients


Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description:	Patients receive androgen-deprivati...	Patients receive androgen-deprivati...
Arm/Group Description:	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Overall Number of Participants Analyzed	397	393
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: proportion of participants
	0.277 (0.234 to 0.324)	0.168 (0.132 to 0.209)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy and Docetaxel, Androgen-Deprivation Therapy Alone
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

6.Secondary Outcome


Title	QOL Change From Baseline to 3 Months
Description	The primary QOL change was evaluated by the Functional Assessment of C...
Description	The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.
Time Frame	Assessed at baseline and 3 months

Outcome Measure Data

Analysis Population Description

Patients with both baseline and 3-month QOL assessments are included in this analysis.


Arm/Group Title	Androgen-Deprivation Therapy and Docetaxel	Androgen-Deprivation Therapy Alone
Arm/Group Description:	Patients receive androgen-deprivati...	Patients receive androgen-deprivati...
Arm/Group Description:	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Overall Number of Participants Analyzed	334	299
Mean (Standard Error) Unit of Measure: units on a scale
	-2.7 (0.9)	-1.1 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy and Docetaxel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0009
	Comments	[Not Specified]
	Method	Wilcoxon signed rank test
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Androgen-Deprivation Therapy Alone
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.40
	Comments	[Not Specified]
	Method	Wilcoxon signed rank test
	Comments	[Not Specified]

Adverse Events

Time Frame	Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description	Submission of late adverse events is required at follow-up visits up to 10 years.

Arm/Group Title	Arm A	Arm B
Arm/Group Description	Patients receive androgen-deprivati...	Patients receive androgen-deprivati...
Arm/Group Description	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
All-Cause Mortality
	Arm A	Arm B
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Arm A	Arm B
	Affected / at Risk (%)	Affected / at Risk (%)
Total	116/390 (29.74%)	12/392 (3.06%)
Blood and lymphatic system disorders
Anemia ^† 1	5/390 (1.28%)	1/392 (0.26%)
Febrile neutropenia ^† 1	24/390 (6.15%)	0/392 (0.00%)
Cardiac disorders
Left ventricular diastolic dysfunction ^† 1	1/390 (0.26%)	0/392 (0.00%)
Left ventricular systolic dysfunction ^† 1	0/390 (0.00%)	1/392 (0.26%)
Cardiac/heart, pain ^† 1	1/390 (0.26%)	0/392 (0.00%)
Ear and labyrinth disorders
Tinnitus ^† 1	1/390 (0.26%)	0/392 (0.00%)
Gastrointestinal disorders
Constipation ^† 1	1/390 (0.26%)	0/392 (0.00%)
Diarrhea w/o prior colostomy ^† 1	4/390 (1.03%)	0/392 (0.00%)
Dyspepsia ^† 1	1/390 (0.26%)	0/392 (0.00%)
Muco/stomatitis by exam, oral cavity ^† 1	2/390 (0.51%)	0/392 (0.00%)
Nausea ^† 1	2/390 (0.51%)	0/392 (0.00%)
Vomiting ^† 1	2/390 (0.51%)	0/392 (0.00%)
Abdomen, pain ^† 1	1/390 (0.26%)	0/392 (0.00%)
General disorders
Fatigue ^† 1	16/390 (4.10%)	1/392 (0.26%)
Death NOS ^† 1	1/390 (0.26%)	0/392 (0.00%)
Edema limb ^† 1	1/390 (0.26%)	0/392 (0.00%)
Immune system disorders
Allergic reaction ^† 1	8/390 (2.05%)	0/392 (0.00%)
Infections and infestations
Infection w/ gr3-4 neut, heart ^† 1	1/390 (0.26%)	0/392 (0.00%)
Infection w/ gr3-4 neut, lung ^† 1	1/390 (0.26%)	0/392 (0.00%)
Infection w/ gr3-4 neut, skin ^† 1	1/390 (0.26%)	0/392 (0.00%)
Infection w/ gr3-4 neut, upper airway ^† 1	2/390 (0.51%)	0/392 (0.00%)
Infection w/ gr3-4 neut, urinary tract ^† 1	1/390 (0.26%)	0/392 (0.00%)
Infection Gr0-2 neut, rectum ^† 1	1/390 (0.26%)	0/392 (0.00%)
Infection Gr0-2 neut, skin ^† 1	1/390 (0.26%)	0/392 (0.00%)
Infection w/ gr3-4 neut, blood ^† 1	1/390 (0.26%)	0/392 (0.00%)
Infection-other ^† 1	1/390 (0.26%)	0/392 (0.00%)
Injury, poisoning and procedural complications
Vascular access,Thrombosis/embolism ^† 1	0/390 (0.00%)	1/392 (0.26%)
Investigations
Leukocytes decreased ^† 1	18/390 (4.62%)	0/392 (0.00%)
Lymphopenia ^† 1	9/390 (2.31%)	0/392 (0.00%)
Neutrophils decreased ^† 1	47/390 (12.05%)	0/392 (0.00%)
Platelets decreased ^† 1	1/390 (0.26%)	0/392 (0.00%)
Weight gain ^† 1	2/390 (0.51%)	0/392 (0.00%)
Alkaline phosphatase increased ^† 1	2/390 (0.51%)	1/392 (0.26%)
Alanine aminotransferase increased ^† 1	1/390 (0.26%)	0/392 (0.00%)
Creatinine increased ^† 1	1/390 (0.26%)	0/392 (0.00%)
Metabolism and nutrition disorders
Pancreatic glucose intolerance ^† 1	0/390 (0.00%)	1/392 (0.26%)
Anorexia ^† 1	0/390 (0.00%)	2/392 (0.51%)
Dehydration ^† 1	2/390 (0.51%)	0/392 (0.00%)
Hyperglycemia ^† 1	3/390 (0.77%)	0/392 (0.00%)
Hyperkalemia ^† 1	1/390 (0.26%)	1/392 (0.26%)
Hyponatremia ^† 1	2/390 (0.51%)	0/392 (0.00%)
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness ^† 1	4/390 (1.03%)	0/392 (0.00%)
Back, pain ^† 1	1/390 (0.26%)	0/392 (0.00%)
Bone, pain ^† 1	2/390 (0.51%)	1/392 (0.26%)
Joint, pain ^† 1	1/390 (0.26%)	0/392 (0.00%)
Muscle, pain ^† 1	3/390 (0.77%)	1/392 (0.26%)
Nervous system disorders
Neuropathy-motor ^† 1	2/390 (0.51%)	0/392 (0.00%)
Neuropathy-sensory ^† 1	2/390 (0.51%)	1/392 (0.26%)
Syncope ^† 1	1/390 (0.26%)	0/392 (0.00%)
Head/headache ^† 1	0/390 (0.00%)	1/392 (0.26%)
Reproductive system and breast disorders
Erectile impotence ^† 1	1/390 (0.26%)	2/392 (0.51%)
Gynecomastia ^† 1	1/390 (0.26%)	1/392 (0.26%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	1/390 (0.26%)	0/392 (0.00%)
Dyspnea ^† 1	2/390 (0.51%)	2/392 (0.51%)
Hiccoughs ^† 1	1/390 (0.26%)	0/392 (0.00%)
Skin and subcutaneous tissue disorders
Nail changes ^† 1	1/390 (0.26%)	0/392 (0.00%)
Skin-other ^† 1	1/390 (0.26%)	0/392 (0.00%)
Vascular disorders
Hypertension ^† 1	1/390 (0.26%)	1/392 (0.26%)
Hot flashes ^† 1	1/390 (0.26%)	1/392 (0.26%)
Thrombosis/thrombus/embolism ^† 1	3/390 (0.77%)	1/392 (0.26%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, CTCAE 3.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Arm A	Arm B
	Affected / at Risk (%)	Affected / at Risk (%)
Total	38/390 (9.74%)	1/392 (0.26%)
General disorders
Fatigue ^† 1	35/390 (8.97%)	1/392 (0.26%)
Skin and subcutaneous tissue disorders
Alopecia ^† 1	22/390 (5.64%)	0/392 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, CTCAE 3.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Study Statistician
Organization:	ECOG-ACRIN Statistical Office
Phone:	617-632-3012

Publications of Results:

Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015 Aug 20;373(8):737-46. doi: 10.1056/NEJMoa1503747. Epub 2015 Aug 5.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lage DE, Michaelson MD, Lee RJ, Greer JA, Temel JS, Sweeney CJ. Outcomes of older men receiving docetaxel for metastatic hormone-sensitive prostate cancer. Prostate Cancer Prostatic Dis. 2021 Dec;24(4):1181-1188. doi: 10.1038/s41391-021-00389-2. Epub 2021 May 18.

Martini A, Pfail J, Montorsi F, Galsky MD, Oh WK. Surrogate endpoints for overall survival for patients with metastatic hormone-sensitive prostate cancer in the CHAARTED trial. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):638-645. doi: 10.1038/s41391-020-0231-5. Epub 2020 Apr 20.

Morgans AK, Chen YH, Sweeney CJ, Jarrard DF, Plimack ER, Gartrell BA, Carducci MA, Hussain M, Garcia JA, Cella D, DiPaola RS, Patrick-Miller LJ. Quality of Life During Treatment With Chemohormonal Therapy: Analysis of E3805 Chemohormonal Androgen Ablation Randomized Trial in Prostate Cancer. J Clin Oncol. 2018 Apr 10;36(11):1088-1095. doi: 10.1200/JCO.2017.75.3335. Epub 2018 Mar 9.

Kyriakopoulos CE, Chen YH, Carducci MA, Liu G, Jarrard DF, Hahn NM, Shevrin DH, Dreicer R, Hussain M, Eisenberger M, Kohli M, Plimack ER, Vogelzang NJ, Picus J, Cooney MM, Garcia JA, DiPaola RS, Sweeney CJ. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial. J Clin Oncol. 2018 Apr 10;36(11):1080-1087. doi: 10.1200/JCO.2017.75.3657. Epub 2018 Jan 31.

Harshman LC, Chen YH, Liu G, Carducci MA, Jarrard D, Dreicer R, Hahn N, Garcia JA, Hussain M, Shevrin D, Eisenberger M, Kohli M, Plimack ER, Cooney M, Vogelzang NJ, Picus J, Dipaola R, Sweeney CJ; ECOG-ACRIN 3805 Investigators. Seven-Month Prostate-Specific Antigen Is Prognostic in Metastatic Hormone-Sensitive Prostate Cancer Treated With Androgen Deprivation With or Without Docetaxel. J Clin Oncol. 2018 Feb 1;36(4):376-382. doi: 10.1200/JCO.2017.75.3921. Epub 2017 Dec 20.

Scott E. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. Sweeney CJ, Chen YH, Carducci M, Liu G, Jarrard DF, Eisenberger M, Wong YN, Hahn N, Kohli M, Cooney MM, Dreicer R, Vogelzang NJ, Picus J, Shevrin D, Hussain M, Garcia JA, DiPaola RS. Department of Medicine; Department of Biostatistics and Computational Biology; Dana-Farber Cancer Institute, Boston; Harvard Medical School, Boston; Johns Hopkins University, Baltimore; University of Wisconsin Carbone Cancer Center; School of Medicine and Public Health; Madison; Fox Chase Cancer Center, Temple University Health System, Philadelphia; Indiana University Melvin and Bren Simon Cancer Center, Indianapolis; Mayo Clinic, Rochester, MN; University Hospitals Case Medical Center, Seidman Cancer Center; Cleveland Clinic Taussig Cancer Institute; Both in Cleveland; University of Virginia Cancer Center, Charlottesville; Comprehensive Cancer Centers of Nevada, Las Vegas; Siteman Cancer Center, Washington University School of Medicine, St. Louis; NorthShore University Health System, Evanston, IL; University of Michigan Comprehensive Cancer Center, Ann Arbor; Rutgers Cancer Institute of New Jersey, New Brunswick.N Engl J Med. 2015 Aug 20;373(8):737-46. [Epub 2015 Aug 5]. doi: 10.1056/NEJMoa1503747. Urol Oncol. 2017 Mar;35(3):123. doi: 10.1016/j.urolonc.2016.12.021. Epub 2017 Feb 1.

Layout table for additonal information

Responsible Party:	Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier:	NCT00309985
Other Study ID Numbers:	E3805 E3805 ( Other Identifier: ECOG-ACRIN Cancer Research Group ) U10CA180794 ( U.S. NIH Grant/Contract )
First Submitted:	March 29, 2006
First Posted:	April 3, 2006
Results First Submitted:	December 17, 2015
Results First Posted:	March 3, 2016
Last Update Posted:	March 18, 2024

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