NCT00033631 · CITED IN SOURCE DOCUMENTS

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2023-01-18

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Overall Survival

→

outcome · POSTED

Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition

→

outcome · POSTED

Disease Specific Survival

→

outcome · POSTED

Local Progression

→

outcome · POSTED

Distant Metastases

→

outcome · POSTED

Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity

→

outcome · POSTED

Percentage of Participants With Erectile Disfuction at 12 Months

→

outcome · POSTED

Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months

→

outcome · POSTED

Quality Adjusted Survival by SQLI

→

outcome · NOT POSTED

Tumor Control Probability

→

outcome · NOT POSTED

Normal Tissue Complication Probability

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Clinical stage T1b-T2b * Meets one of the following criteria: * Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but \< 20 ng/mL * Gleason score 7 AND PSA \< 15 ng/mL * No regional lymph node involvement * No distant metastases PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer * No other major medical or psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior cytotoxic chemotherapy * No concurrent cytotoxic chemotherapy Endocrine therapy: * At least 3 months since prior finasteride * No other prior hormonal therapy, including: * Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide) * Antiandrogens (e.g., flutamide or bicalutamide) * Estrogens (e.g., diethylstilbestrol) * No concurrent (neoadjuvant or adjuvant) hormonal therapy Radiotherapy: * No prior pelvic irradiation or brachytherapy Surgery: * No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer * No prior surgical castration (bilateral orchiectomy) Other: * At least 3 months since prior finasteride or phytoestrogen preparation (PC-SPES)
healthy Volunteers: false
minimum Age: 18 Years
sex: MALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
70.2 Gy 3D-CRT/IMRT
intervention Names
Radiation: 70.2 Gy 3D-CRT/IMRT
label
70.2 Gy
type
ACTIVE_COMPARATOR
description
79.2 Gy 3D-CRT/IMRT
intervention Names
Radiation: 79.2 Gy 3D-CRT/IMRT
label
79.2 Gy
type
EXPERIMENTAL

interventions

arm Group Labels
70.2 Gy
description
Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
name
70.2 Gy 3D-CRT/IMRT
other Names
3D conformal radiation therapy
intensity modulated radiation therapy
type
RADIATION
arm Group Labels
79.2 Gy
description
Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
name
79.2 Gy 3D-CRT/IMRT
other Names
3D conformal radiation therapy
intensity modulated radiation therapy
type
RADIATION

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 1534
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.
measure
Overall Survival
time Frame
From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.

secondary Outcomes

description
Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact.
measure
Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition
time Frame
From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years.
description
Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy.
measure
Disease Specific Survival
time Frame
From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint.
description
Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.
measure
Local Progression
time Frame
From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
description
Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.
measure
Distant Metastases
time Frame
From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
description
Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0
measure
Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity
time Frame
From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint
description
The International Index of Erectile Function Questionnaire (IIEF) is the primary measure for erectile function (ED). IIEF question number 1 ("How often were you able to get an erection during sexual activity?") is scored from: none/almost never (response 0-1) or \< half the time (response 2-3) to most times/almost always/always (response 4-5). A response of 0 to 3 on question number 1 of the IIEF is considered erectile dysfunction.
measure
Percentage of Participants With Erectile Disfuction at 12 Months
time Frame
Twelve months from randomization
description
The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows: Improvement: when change \>= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM \< change \< SEM; Declined: when change \<= SEM.
measure
Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months
time Frame
Baseline and 12 months from randomization
measure
Quality Adjusted Survival by SQLI
time Frame
From randomization to 5 years.
measure
Tumor Control Probability
time Frame
From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis.
measure
Normal Tissue Complication Probability
time Frame
From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis.

Full study description

brief Summary: RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.
detailed Description: OBJECTIVES: * Compare the overall survival of patients with stage II adenocarcinoma of the prostate treated with high- vs standard-dose three-dimensional conformal or intensity-modulated radiotherapy. * Compare the freedom from prostate-specific antigen failure, disease-specific survival, local progression, and distant metastases in patients treated with these regimens. * Compare the probability of tumor control and normal tissue complications in patients treated with these regimens. * Compare the incidence of grade 2 or greater genitourinary and gastrointestinal acute and late toxicity in patients treated with these regimens. * Compare the quality of life, including sexual function, of patients treated with these regimens. * Correlate histopathologic or tumor-specific cytogenetic or chromosomal markers with cancer control outcomes in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score and prostate-specific antigen (PSA) level (Gleason score 2-6, PSA ≥10 mg/mL but \< 20 ng/mL vs Gleason score 7, PSA \< 15 ng/mL) and radiation modality (three-dimensional conformal radiotherapy \[3D-CRT\] vs intensity-modulated radiotherapy \[IMRT\]). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo standard-dose 3D-CRT or IMRT once daily, 5 days a week, for 7.8 weeks (39 treatment days). * Arm II: Patients undergo high-dose 3D-CRT or IMRT once daily, 5 days a week, for 8.8 weeks (44 treatment days). Quality of life (QOL) is assessed initially at baseline. After completion of radiotherapy, QOL is assessed every 3 months for 1 year and then every 6 months for 4 years. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,520 patients (760 per treatment arm) will be accrued for this study within 5 years.

Source references

references

citation
Cranmer-Sargison G. A treatment planning investigation into the dosimetric effects of systematic prostate patient rotational set-up errors. Med Dosim. 2008 Autumn;33(3):199-205. doi: 10.1016/j.meddos.2007.06.005.
pmid
18674684
type
BACKGROUND
citation
Potrebko PS, McCurdy BM, Butler JB, El-Gubtan AS, Nugent Z. Optimal starting gantry angles using equiangular-spaced beams with intensity modulated radiation therapy for prostate cancer on RTOG 0126: a clinical study of 5 and 7 fields. Radiother Oncol. 2007 Nov;85(2):299-305. doi: 10.1016/j.radonc.2007.06.019. Epub 2007 Sep 7.
pmid
17825932
type
RESULT
citation
Spratt DE, Tang S, Sun Y, Huang HC, Chen E, Mohamad O, Armstrong AJ, Tward JD, Nguyen PL, Lang JM, Zhang J, Mitani A, Simko JP, DeVries S, van der Wal D, Pinckaers H, Monson JM, Campbell HA, Wallace J, Ferguson MJ, Bahary JP, Schaeffer EM, Sandler HM, Tran PT, Rodgers JP, Esteva A, Yamashita R, Feng FY. Artificial Intelligence Predictive Model for Hormone Therapy Use in Prostate Cancer. NEJM Evid. 2023 Aug;2(8):EVIDoa2300023. doi: 10.1056/EVIDoa2300023. Epub 2023 Jun 29.
pmid
38320143
type
DERIVED
citation
Alexander GS, Krc RF, Assif JW, Sun K, Molitoris JK, Tran P, Rana Z, Bentzen SM, Mishra MV. Conditional Risks of Biochemical Failure and Prostate Cancer-Specific Death in Patients Undergoing External Beam Radiotherapy: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2023 Sep 5;6(9):e2335069. doi: 10.1001/jamanetworkopen.2023.35069.
pmid
37751207
type
DERIVED
citation
Spratt DE, Liu VYT, Michalski J, Davicioni E, Berlin A, Simko JP, Efstathiou JA, Tran PT, Sandler HM, Hall WA, Thompson DJS, Parliament MB, Dayes IS, Correa RJM, Robertson JM, Gore EM, Doncals DE, Vigneault E, Souhami L, Karrison TG, Feng FY. Genomic Classifier Performance in Intermediate-Risk Prostate Cancer: Results From NRG Oncology/RTOG 0126 Randomized Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):370-377. doi: 10.1016/j.ijrobp.2023.04.010. Epub 2023 May 2.
pmid
37137444
type
DERIVED
citation
Kim S, Kong JH, Lee Y, Lee JY, Kang TW, Kong TH, Kim MH, You SH. Dose-escalated radiotherapy for clinically localized and locally advanced prostate cancer. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD012817. doi: 10.1002/14651858.CD012817.pub2.
pmid
36884035
type
DERIVED
citation
Michalski JM, Moughan J, Purdy J, Bosch W, Bruner DW, Bahary JP, Lau H, Duclos M, Parliament M, Morton G, Hamstra D, Seider M, Lock MI, Patel M, Gay H, Vigneault E, Winter K, Sandler H. Effect of Standard vs Dose-Escalated Radiation Therapy for Patients With Intermediate-Risk Prostate Cancer: The NRG Oncology RTOG 0126 Randomized Clinical Trial. JAMA Oncol. 2018 Jun 14;4(6):e180039. doi: 10.1001/jamaoncol.2018.0039. Epub 2018 Jun 14.
pmid
29543933
type
DERIVED