NCT00030654|CompletedPhase 3DMC

Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

A Phase III Randomized Study of Patients With High Risk, Hormone-Naive Prostate Cancer: Androgen Blockade With 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade With Delayed Chemotherapy

Radiation Therapy Oncology Group ClinicalTrials.gov

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5 other identifiers

RTOG-P-0014CDR0000069186ECOG-RTOG-P-0014CALGB-RTOG-P-0014SWOG-RTOG-P-0014

Study Type

interventional

Target

Locations

4 countries

Sites

Timeline

RegisteredJan 2003

StartedOct 2002

CompletionFeb 2005

Brief Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the same time as hormone therapy is more effective than chemotherapy given after hormone therapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have prostate cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3 prostate-cancer

Timeline

Completed

Started Oct 2002

Shorter than P25 for phase_3 prostate-cancer

Geographic Reach

4 countries

78 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

First Submitted

Initial submission to the registry

February 14, 2002

Completed

8 months until next milestone

Study Start

First participant enrolled

October 1, 2002

Completed

4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2005

Completed

Last Updated

October 22, 2020

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

February 14, 2002

Last Update Submit

October 21, 2020

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancerrecurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

Overall Survival
From date of randomization to the date of death due to any cause

Secondary Outcomes (3)

Biochemical control
From date of randomization to the date of first PSA failure defined as a PSA doubling time <= 32 weeks
Time to Clinical Failure
Time from study entry to positive scan or positive disease evaluation of the pelvis or chest or a PSA doubling time ≤ 32 weeks
Frequency of non-hematologic (>= grade 3), hematologic (grade >=4) and fatal (grade 5) toxicities
From the beginning of treatment to 90 days post treatment

Study Arms (2)

Androgen blockade + immediate chemotherapy

EXPERIMENTAL

Androgen blockade with immediate chemotherapy

Drug: bicalutamideDrug: docetaxelDrug: doxorubicin hydrochlorideDrug: estramustine phosphate sodiumDrug: flutamideDrug: ketoconazoleDrug: paclitaxelDrug: releasing hormone agonist therapyDrug: vinblastine sulfate

Androgen blockade + delayed chemotherapy

EXPERIMENTAL

Androgen blockade with delayed chemotherapy