Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Screening Closed 55 to 74 NCI PLCO-1 NCI-P93-0050, NCT00002540

Objectives

I.  Determine whether screening with flexible sigmoidoscopy and chest x-ray 
can reduce mortality from colorectal and lung cancer, respectively, in men and 
women aged 55-74.

II.  Determine whether screening with digital rectal examination (DRE) plus 
serum prostate-specific antigen (PSA) can reduce mortality from prostate 
cancer in men aged 55-74.

III.  Determine whether screening with CA 125 and transvaginal ultrasound can 
reduce mortality from ovarian cancer in women aged 55-74.

IV.  Assess other screening variables for each of the above interventions 
including sensitivity, specificity, and positive predictive value.

V.  Assess the incidence, stage, and survival experience 
of cancer cases.

VI.  Investigate the mortality predictive value of biologic and/or prognostic 
characterizations of tumor tissue as intermediate endpoints.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 No prior or concurrent finasteride for benign prostatic hypertrophy

Radiotherapy:
 Not specified

Surgery:
 No prior surgical removal of the entire colon, one lung, or the entire
 prostate

Other:
 No concurrent treatment for cancer other than nonmelanomatous skin cancer

Patient Characteristics:

Men and women aged 55-74 with no known prior cancer of the colon, rectum,
lung, prostate, or ovary
  No routine surveillance for a medical condition involving the above sites

No participation in another cancer screening or primary prevention trial

General Eligibility Criteria:

--Patient Characteristics--

Men and women aged 55-74 with no known prior cancer of the colon, rectum,
lung, prostate, or ovary
  No routine surveillance for a medical condition involving the above sites

No participation in another cancer screening or primary prevention trial

--Prior/Concurrent Therapy--

Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 No prior or concurrent finasteride for benign prostatic hypertrophy

Radiotherapy:
 Not specified

Surgery:
 No prior surgical removal of the entire colon, one lung, or the entire
 prostate

Other:
 No concurrent treatment for cancer other than nonmelanomatous skin cancer

Expected Enrollment

A total of 74,000 women and 74,000 men (37,000 for each gender/arm) will be 
accrued for this study from 10 screening centers (10,000-20,000/center). 

Outline

This is a randomized study. Patients are stratified by participating center, 
gender, and age (55-59 vs 60-64 vs 65-69 vs 70-74). Patients are randomized to 
one of two treatment arms.

Arm I (Control): Patients receive standard medical care.

Arm II:  All patients undergo an initial sigmoidoscopic examination and chest 
x-ray; men also undergo DRE and PSA testing and women undergo a transvaginal 
ultrasound and CA 125 test. A scheduling and tracking procedure is implemented 
to ensure regular attendance at repeat screens for subjects screened negative 
or for those who are designated suspicious or positive at screening but for 
whom subsequent diagnostic procedures do not reveal prostate, lung, 
colorectal, or ovarian cancer (follow-up diagnostic procedures are through 
their own medical care environment). Patients diagnosed via a screening test 
with cancer of the prostate, lung, colorectum, or ovary are referred for 
treatment in accordance with current accepted practice for appropriate stage 
of disease, patient age, and medical condition; a procedure is provided for 
contact with qualified medical personnel to insure appropriate therapy. DRE 
(men only), transvaginal ultrasound (women only), and chest x-ray are repeated 
annually for 3 years. Patients who have never smoked do not receive a third 
chest x-ray. PSA testing (men only) and CA 125 tests (women only) are repeated 
annually for 5 years; the sigmoidoscopic exam is repeated 5 years after the 
initial exam. 

A Periodic Survey of Health questionnaire is mailed to each participant 
annually for 13 years to identify all prevalent and incident cancers of the 
prostate, lung, colorectum, and ovary as well as all deaths that occur among 
both screened and control subjects during the trial.

Ahn J, Albanes D, Peters U, et al.: Dairy products, calcium intake, and risk of prostate cancer in the prostate, lung, colorectal, and ovarian cancer screening trial. Cancer Epidemiol Biomarkers Prev 16 (12): 2623-30, 2007.[PUBMED Abstract]

Andriole GL, Levin DL, Crawford ED, et al.: Prostate cancer screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial: findings from the initial screening round of a randomized trial. J Natl Cancer Inst 97 (6): 433-8, 2005.[PUBMED Abstract]

Berndt SI, Huang WY, Chatterjee N, et al.: Transforming growth factor beta 1 (TGFB1) gene polymorphisms and risk of advanced colorectal adenoma. Carcinogenesis 28 (9): 1965-70, 2007.[PUBMED Abstract]

Buys SS, Partridge E, Greene MH, et al.: Ovarian cancer screening in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial: findings from the initial screen of a randomized trial. Am J Obstet Gynecol 193 (5): 1630-9, 2005.[PUBMED Abstract]

Gohagan JK, Kramer BS, Greenwald P: "Screening for prostate cancer". Am J Prev Med 10 (4): 245-6, 1994 Jul-Aug.[PUBMED Abstract]

Gohagan JK, Prorok PC, Kramer BS, et al.: Prostate cancer screening in the prostate, lung, colorectal and ovarian cancer screening trial of the National Cancer Institute. J Urol 152 (5 Pt 2): 1905-9, 1994.[PUBMED Abstract]

Grubb RL 3rd, Pinsky PF, Greenlee RT, et al.: Prostate cancer screening in the Prostate, Lung, Colorectal and Ovarian cancer screening trial: update on findings from the initial four rounds of screening in a randomized trial. BJU Int 102 (11): 1524-30, 2008.[PUBMED Abstract]

Hayes RB, Sigurdson A, Moore L, et al.: Methods for etiologic and early marker investigations in the PLCO trial. Mutat Res 592 (1-2): 147-54, 2005.[PUBMED Abstract]

Kirsh VA, Hayes RB, Mayne ST, et al.: Supplemental and dietary vitamin E, beta-carotene, and vitamin C intakes and prostate cancer risk. J Natl Cancer Inst 98 (4): 245-54, 2006.[PUBMED Abstract]

Kirsh VA, Peters U, Mayne ST, et al.: Prospective study of fruit and vegetable intake and risk of prostate cancer. J Natl Cancer Inst 99 (15): 1200-9, 2007.[PUBMED Abstract]

Lacey JV Jr, Greene MH, Buys SS, et al.: Ovarian cancer screening in women with a family history of breast or ovarian cancer. Obstet Gynecol 108 (5): 1176-84, 2006.[PUBMED Abstract]

Miller JH, Kramer BS, Kreimer AR, et al.: Cumulative false-positives (FP) in the prostate, lung, colorectal, ovarian (PLCO) cancer screening trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-1503, 2007.

Moore SM, Gierada DS, Clark KW, et al.: Image quality assurance in the prostate, lung, colorectal, and ovarian cancer screening trial network of the National Lung Screening Trial. J Digit Imaging 18 (3): 242-50, 2005.[PUBMED Abstract]

Oken MM, Marcus PM, Hu P, et al.: Baseline chest radiograph for lung cancer detection in the randomized Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. J Natl Cancer Inst 97 (24): 1832-9, 2005.[PUBMED Abstract]

Partridge E, Kreimer AR, Buys SS, et al.: Ovarian cancer screening in the prostate, lung, colorectal and ovarian cancer screening trial: results from 4 years of annual screening in a randomized trial. [Abstract] Society of Gynecologic Oncologists, 2007 Annual Meeting on Women's Cancer, March 3-7, 2007, San Diego, CA. A-27, 2007.

Pinsky PF, Andriole GL, Kramer BS, et al.: Prostate biopsy following a positive screen in the prostate, lung, colorectal and ovarian cancer screening trial. J Urol 173 (3): 746-50; discussion 750-1, 2005.[PUBMED Abstract]

Pinsky PF, Crawford ED, Kramer BS, et al.: Repeat prostate biopsy in the prostate, lung, colorectal and ovarian cancer screening trial. BJU Int 99 (4): 775-9, 2007.[PUBMED Abstract]

Pinsky PF, Miller A, Kramer BS, et al.: Evidence of a healthy volunteer effect in the prostate, lung, colorectal, and ovarian cancer screening trial. Am J Epidemiol 165 (8): 874-81, 2007.[PUBMED Abstract]

Pinsky PF, Schoen RE, Weissfeld JL, et al.: Variability in flexible sigmoidoscopy performance among examiners in a screening trial. Clin Gastroenterol Hepatol 3 (8): 792-7, 2005.[PUBMED Abstract]

Purdue MP, Mink PJ, Hartge P, et al.: Hormone replacement therapy, reproductive history, and colorectal adenomas: data from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial (United States). Cancer Causes Control 16 (8): 965-73, 2005.[PUBMED Abstract]

Schoen RE, Weissfeld JL, Kuller LH, et al.: Insulin-like growth factor-I and insulin are associated with the presence and advancement of adenomatous polyps. Gastroenterology 129 (2): 464-75, 2005.[PUBMED Abstract]

Tammemagi CM, Freedman MT, Church TR, et al.: Factors associated with human small aggressive non small cell lung cancer. Cancer Epidemiol Biomarkers Prev 16 (10): 2082-9, 2007.[PUBMED Abstract]

Wang SS, Morton LM, Bergen AW, et al.: Genetic variation in catechol-O-methyltransferase (COMT) and obesity in the prostate, lung, colorectal, and ovarian (PLCO) cancer screening trial. Hum Genet 122 (1): 41-9, 2007.[PUBMED Abstract]

Weiss JM, Huang WY, Rinaldi S, et al.: Endogenous sex hormones and the risk of prostate cancer: a prospective study. Int J Cancer 122 (10): 2345-50, 2008.[PUBMED Abstract]

Danforth KN, Hayes RB, Rodriguez C, et al.: Polymorphic variants in PTGS2 and prostate cancer risk: results from two large nested case-control studies. Carcinogenesis 29 (3): 568-72, 2008.[PUBMED Abstract]

Pinsky PF, Ford M, Gamito E, et al.: Enrollment of racial and ethnic minorities in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. J Natl Med Assoc 100 (3): 291-8, 2008.[PUBMED Abstract]

Trauth JM, Jernigan JC, Siminoff LA, et al.: Factors affecting older african american women's decisions to join the PLCO Cancer Screening Trial. J Clin Oncol 23 (34): 8730-8, 2005.[PUBMED Abstract]

Kramer BS, Gohagan J, Prorok PC: NIH Consensus 1994: screening. Gynecol Oncol 55 (3 Pt 2): S20-1, 1994.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCI - Early Detection Branch

Christine Berg, MD, Protocol chair		Ph: 301-496-8544 Email: bergc@mail.nih.gov

Registry Information
Official Title		PROTOCOL FOR THE NCI PROSTATE, LUNG, COLORECTAL, AND OVARIAN (PLCO) CANCER SCREENING TRIAL
Trial Start Date		1993-11-16
Registered in ClinicalTrials.gov		NCT00002540
Date Submitted to PDQ		1993-11-16
Information Last Verified		2009-01-16