PRIAS project - Active surveillance -

Announcement press release

Dear PRIAS members,

The development of imaging methods to improve the diagnosis and characterization of prostate cancer does not stand still. This implies that long-term studies like PRIAS have to adapt accordingly.

In this view, we are very happy and proud to inform you that a completely updated PRIAS protocol is now online (www.prias-project.org).

Please read the complete protocol on C1 Protocol Version 6.0 or the pocket guideline on Pocket Guide 6.0 .

Changing the protocol implies that our website needed updates to match updated inclusion and recommendations

In this email, we will give a short update of the most important changes:

    1. The use of MRI with possible targeted biopsies has improved sampling accuracy and, as such, the general feeling is that widening of the inclusion criteria is appropriate.

The most important changes to the Inclusion criteria are:
    -   If an MRI is used at inclusion or will be used during follow up, there is no limit in the number of positive cores.
    -   Patient with Gleason score 3+4 without invasive cribriform and intraductal carcinoma are allowed in the PRIAS study if the number of positive cores is ≤ 50%, where multiple positive cores from the same lesion on MRI count for one positive core.
    -   Please view the complete inclusion criteria on Inclusion criteria
To allow patients with prostate cancer Gleason score 3+4 without invasive cribriform and intraductal carcinoma to be included in the PRIAS study we created a new variable, namely, Does it have presence of cribriform/intraductal carcinoma * which can be answered with yes, no or unknown.

If the answer is unknown, a patient with Gleason 3+4 can be included and follow-up outside the actual protocol.

    2. The follow-up protocol of the MRI side study has become the standard advised protocol:

Here, the most important change is the advice to perform an MRI with possible targeted biopsies 3 months after diagnosis if no MRI is performed before diagnosis.

At 1, 4, 7 and 10 years and subsequently every 5 years now systematic biopsies together with MRI and possible targeted biopsies are recommended.

Another important change is that if the PSA doubling time is between 0 and 10 years not yearly systematic biopsies are recommended, but yearly MRI with only targeted biopsies if there is a new lesion or progression of a known lesion.

Below we outlined the most important changes in the PRIAS protocol.

    3. Finally, the reasons for discontinuation have been updated:
    -   Clinical stage cT3 or higher (stays the same).
    -   Gleason score 3+4 without invasive cribriform and intraductal carcinoma but more than 50% of the biopsies are positive for prostate cancer (where multiple positive cores from the same lesion on MRI count for one positive core).
    -   Gleason score 3+4 with invasive cribriform and intraductal carcinoma or Gleason score 4+3 or higher.
    -   If the life expectancy falls below 10 years, watchful waiting is preferred above active surveillance.
    -   The recommendation trees shown on the website have been altered accordingly.

    4. Patient information leaflet.
Along with the update of the PRIAS protocol, the patient information leaflet has been updated and translated into various languages. You can find the translated patient information leaflets on the website in the right border.

We would like to thank everybody who helped in creating an accurate translation of the document.

Now the protocol is updated and implemented on the website we will start with updating the look and feel of the website. Please allow us some time to implement all your previously given suggestions.

For now, we hope the updates will help you in daily clinical practice. From this moment on they are online.

If you encounter any problems or errors on the website, please send me an email, if you have any other questions, please feel free to ask!

On behalf of Prof. Roobol (and Prof. Bangma) and the PRIAS steering committee

Yours sincerely,

Henk B. Luiting MSc
MD – PhD Candidate
Urology

P.O. Box 2040, 3000 CA Rotterdam, The Netherlands
Visiting address: office Na-1514, Dr.Molewaterplein 40, 3015 GD Rotterdam, The Netherlands
Email: h.luiting@erasmusmc.nl | Telephone +31 10 703 22 43 | Fax +31 10 703 22 43
www.erasmusmc.nl

Active surveillance of early prostate cancer

Screening has resulted in a marked increase in the number of newly diagnosed prostate cancers, while it is unclear whether the early detection of these tumors reduces the prostate cancer mortality. (1)

Up to 80% of men with PSA screen-detected prostate cancer are overdiagnosed, that is, their cancer would never have caused any symptoms. (2) Overdiagnosis would matter less if treatment had no adverse effects. (3,4)

It would be more acceptable to treat all cases, including those destined never to cause symptoms, if treatment was problem-free. However, while radical treatment for prostate cancer may or may not improve a man's longevity, it can certainly have a big impact on his lifestyle. Ideally, such intervention should be restricted to those who need it. Active surveillance aims to individualize the management of early prostate cancer by selecting only those men with significant cancers for curative treatment. (5,6)

Patients on active surveillance are closely monitored using serum PSA levels and repeat prostate biopsies. The choice between curative treatment and continued observation is based on evidence of disease progression during this monitoring. Active surveillance must be distinguished from watchful waiting, which for decades has described a policy of observation with the use of palliative treatment for symptomatic progression. Put another way in order to emphasize the differences between these two contrasting approaches, whereas watchful waiting involves relatively lax observation with late, palliative treatment for those who develop symptoms of progressive disease, active surveillance involves close monitoring with early, curative treatment in those with evidence of biochemical or histological progression.

PRIAS (Prostate cancer Research International: Active Surveillance) presents a program in which selected men with early prostate cancer are managed by a protocolized follow-up strategy. Candidates for this program are: men fit for curative therapy, PSA at diagnosis less than 10 ng/mL, PSA density (PSA/prostatic volume) less than 0.20, one or two biopsy cores bearing prostate cancer (using a fixed volume-dependent number of cores), Gleason score 3+3 and digital rectal examination T1c or T2. If an MRI is used before diagnosis or if an MRI will be used during follow-up the inclusion criteria are: men fit for curative therapy, PSA at diagnosis less than 20 ng/ml, PSA density less than 0.25, Gleason score 3+3 or Gleason score 3+4 without invasive cribriform and intraductal carcinoma (CR/IDC) and digital rectal examination T1c or T2. In patients with Gleason score 3+3 there is no limit in the number of positive cores. In patients with Gleason score 3+4 without CR/IDC, the maximum number of positive cores should be ≤ 50%, where multiple positive cores from the same lesion on MRI count for one positive core.

The current program is registered at the Dutch Trial Register with ID: NTR1718

View largest participating Medical centers

View all contributors per Medical center

Contact H.B. Luiting for more information.

References

1. Jemal A, Murray T, Ward E, et al. Cancer statistics, 2005. CA Cancer J Clin 2005;55(1):10-30.
2. Yao SL, Lu-Yao G. Understanding and appreciating overdiagnosis in the PSA era. J Natl Cancer Inst 2002;94(13):958-60.
3. Penson DF, Litwin MS, Aaronson NK. Health related quality of life in men with prostate cancer. J Urol 2003;169(5):1653-61.
4. Fransson P, Widmark A. Late side effects unchanged 4-8 years after radiotherapy for prostate carcinoma: a comparison with age-matched controls. Cancer 1999;85(3):678-88.
5. Klotz LH. Active surveillance with selective delayed intervention: walking the line between overtreatment for indolent disease and undertreatment for aggressive disease. Can J Urol 2005;12 Suppl 1:53-7; discussion 101-2.
6. Parker C. Active surveillance: an individualized approach to early prostate cancer. BJU Int 2003;92(1):2-3.