NCT00067015

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue and may improve quality of life and help patients live more comfortably. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and bicalutamide may fight cancer by stopping the production of androgens. It is not yet known whether radiation therapy is more effective with or without goserelin and bicalutamide in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy with or without bicalutamide and goserelin in treating patients who have prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_3 prostate-cancer

Timeline
Completed

Started May 2003

Typical duration for phase_3 prostate-cancer

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2003

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

1.4 years

First QC Date

August 8, 2003

Last Update Submit

December 21, 2015

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage III prostate cancer

Outcome Measures

Primary Outcomes (1)

  • compare the quality of life

    2 years

Secondary Outcomes (2)

  • response

    2 years

  • toxicity

    2 years

Study Arms (2)

IMRT alone to 86.4 Gy

EXPERIMENTAL

External radiotherapy is given for 10 weeks, Monday through Friday for a total of 48 sessions. The total dose of radiotherapy delivered during these 10 weeks is 86.4 Gy. The radiation treatments are delivered with a high precision technique called intensity modulated radiotherapy or IMRT. For this treatment, no hormonal therapy is required.

Procedure: assessment of therapy complicationsProcedure: quality-of-life assessmentRadiation: radiation therapy

IMRT TO 75.6 Gy plus Adjuvant Androgen Deprivation

EXPERIMENTAL

Prior to a planned course of radiotherapy, which will last for eight and a half weeks, 10 weeks of hormonal therapy are given. The hormonal therapy will start with a daily pill called Casodex. Three to seven days after starting this pill, a Zoladex injection will be administered in addition to the Casodex pill. Zoladex hormonal therapy is given in the form of a monthly injection. After 10 weeks from the initiation of hormone therapy, you will begin external radiotherapy. For these treatments only 42 treatment sessions are given. The total dose of radiotherapy delivered during these 8.5 weeks is 75.6 Gy. The hormone injections continue during the radiation treatments and for 2 years after the radiation treatments. The pills are only taken for the 10 weeks before and also during the radiation treatments, however afterwards the pills are discontinued.

Drug: bicalutamideDrug: goserelin acetateProcedure: assessment of therapy complicationsProcedure: quality-of-life assessmentRadiation: radiation therapy

Interventions

bicalutamideDRUG
IMRT TO 75.6 Gy plus Adjuvant Androgen Deprivation
goserelin acetateDRUG
IMRT TO 75.6 Gy plus Adjuvant Androgen Deprivation
assessment of therapy complicationsPROCEDURE
IMRT TO 75.6 Gy plus Adjuvant Androgen DeprivationIMRT alone to 86.4 Gy
quality-of-life assessmentPROCEDURE
IMRT TO 75.6 Gy plus Adjuvant Androgen DeprivationIMRT alone to 86.4 Gy
radiation therapyRADIATION
IMRT TO 75.6 Gy plus Adjuvant Androgen DeprivationIMRT alone to 86.4 Gy

Eligibility Criteria

Age18 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Unfavorable-risk disease, including at least 2 of the following characteristics: * Prostate-specific antigen level greater than 10 ng/mL * Gleason score greater than 7 * Stage T4 * Intermediate-risk disease with a Gleason score of at least 8 allowed * Lymph nodes clinically negative by imaging studies or histologically negative by node sampling or lymph node dissection * Prostate size less than 75 grams * No distant metastases by bone scan, CT scan, or MRI PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 80-100% Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT and SGPT no greater than 1.5 times ULN Renal * Not specified Other * No documented history of inflammatory bowel disease * No bilateral hip replacements * No other invasive cancer except localized basal cell or squamous cell skin cancer unless disease free for at least 5 years * No major medical or psychiatric illness that would preclude study completion, compliance, or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for prostate cancer Endocrine therapy * No prior androgen-deprivation therapy Radiotherapy * No prior pelvic radiotherapy * No prior prostate brachytherapy Surgery * No prior bilateral orchiectomy * No prior radical prostatectomy * No prior cryotherapy for prostate cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamideGoserelinRadiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsTherapeutics

Study Officials

  • Michael J. Zelefsky, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2003

First Posted

August 11, 2003

Study Start

May 1, 2003

Primary Completion

October 1, 2004

Study Completion

September 1, 2008

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations

US(1)