Relevant Medical Research in Plain English

• What are the European and N. American cancer trials?

• Is there a benefit from screening for prostate cancer?

What are the European and N. American cancer trials?

Large-scale Randomised Prostate Cancer Screening Trials: Program Performances in the 'European Randomized Screening For Prostate Cancer Trial' and the 'Prostate, Lung, Colorectal and Ovary Cancer Trial'.

Authors: Harry J. de Koning, Anssi Auvinen, Antonio Berenguer Sanchez, Fernando Calais da Silva, Stefano Ciatto,Louis Denis, John K. Gohagan, Matti Hakama, Jonas Hugosson, Ries, Kranse, Vera Nelen, Philip C. Prorok, Fritz H.Schroder.

Date: 1992 - 2001

No. of Subjects: The target number of men is 260,000 - 120,000 in the intervention group and 140,000 in the controlgroup. By the end of 1998, 83% of this target had been reached with 218,000 men enrolled - 102,691 allocated to theintervention group and 115,322 allocated to the control group.

Outline: Two large-scale randomized screening trials are currently underway:

· ERSPC – European Randomised Screening for Prostate Cancer
· PLCO – Prostate, Lung, Colorectal and Ovary cancer trial (USA)

The aim of the trials is to assess whether screening reduces prostate cancer mortality. The principal screening method is determination of serum prostate specific antigen (PSA test). The DRE is used in all PLCO & some European centres as an ancillary screening test.

The core age group is 55-69 years at age of entry. Men as young as 50 and as old as 74 have also been recruited but only at 17% of the trial population. Seven European countries and 10 screening centres in USA are participating in the trials. All centres represent a randomized population base or a volunteer population base sample. It is considered that even though the volunteers may not necessarily be representative of the whole population, they are likely to resemble the group that would participate if screening was introduced as a routine policy.

Key findings: In the core age group 10% of men screened had a serum PSA concentration of 4 ng/ml or greater. 7-15% of screened men had a serum PSA concentration of 4 ng/ml or greater, calling for further assessment. 33-50% of men screened had serum PSA concentrations below 1 ng/ml. A substantial number of early prostate cancers have been detected. Of the participants in the ERSPC trial, 69-94% with a PSA level of 4 ng/ml or greater, underwent biopsy. A similar detection rate emerged throughout the ERSPC of 21-28%.

Comment: Comprehensive information on the PLCO trail is not yet available. The trials have the power to show definitive results in 2008.

Reference: Int. J Cancer: 97, 237-244 (2002)

Is there a benefit from screening for prostate cancer?

Overall and Disease-Specific Survival of Patients with Screen-detected Prostate Cancer in the European Randomized Study of Screening for Prostate Cancer, Section Rotterdam.

Authors: Stijn H. de Vries, Renske Postma, Rene Raaijmakers, Stijn Roemeling, Suzie Otto, Harry J. de Kronig, Fritz H. Schroder.

Date: December 1993 to March 2000

No. of Subjects: 42,375 randomised; 21,210 in the screen group and 21,660 in the control group aged between 55 and 75.

Key findings: Of the 21,210 (94.2%) screened in the first round, 4624 (23.2%) were biopsy indicated based on PSA reading greater than or equal to 3.0 ng/ml. Of these 4117 (89.0%) were actually biopsied and during prevalence screening 1014 patients were diagnosed with prostate cancer. At 55 months 126 (12.4%) had died with 20 (2%) having died of prostate cancer. Analysis showed that a Gleason score of 4+4 or higher was predictive of prostate cancer death.

Comment: Of the 1014 men diagnosed with PC 39.3% underwent radical prostectamy, 48.4% radiation therapy, 10% watchful waiting and 2.2% endocrine therapy. This report describes, for the first time, the overall and disease specific survival rates of patients diagnosed with PC during the first round of screening. The goal of this early study is to put survival rates into perspective with current literature and with regional mortality data. Observed survival data are in line with literature and the expected favourable outcome for a screened population. Prostate cancer has a protracted natural course in the majority of cases. Treatment after early diagnosis, facilitated by screening, could possibly improve disease-specific survival