Prostate cancer is the most commonly diagnosed cancer in men with more than 417,000 new cases and 92,000 deaths in Europe recorded each year. Currently, 1 in 7 men in Europe will develop detectable prostate cancer before the age of 85. More than two million men in Europe are living with this disease, today (1).
The EORTC Genito-urinary Cancers Group in the collaboration with the EORTC Radiation Oncology Group, has conducted major practice changing phase III trials in prostate cancer. Research has focused on the role of hormone therapy in metastatic and advanced prostate cancer and the benefit of external beam radiation therapy (EBRT). The groups demonstrated that long-term adjuvant hormone therapy benefits locally advanced prostate cancer patients treated with EBRT. The EORTC-22863 study showed that in addition to EBRT, 3 years of androgen deprivation therapy increase the 5 year overall survival by 15%. The benefit was maintained for 10 years (2). EORTC-22961 trial compared 6 months to 3 years treatment of androgen deprivation therapy. It showed a 5% greater 5-Year overall survival with the longer therapy regimen (3).
EORTC-30891 trial (4) compared immediate versus deferred androgen deprivation therapy in 985 patients with Prostate cancer. Immediate treatment resulted in fewer non prostate cancer deaths. However, time to neither castration-resistant disease nor prostate cancer specific survival differed. Greatest benefit of immediate therapy was seen in older patients with higher PSA (Prostate-Specific Antigen) who were at a higher risk of dying from the cancer. Nevertheless, those patients with a low PSA could be spared the burden of immediate androgen deprivation therapy.
“These important studies changed how locally advanced prostate cancer patients are managed,” said Laurence Collette, Head of Statistics Department, EORTC Headquarters, Brussels, Belgium. “The combination of androgen deprivation therapy and radiotherapy improved patient survival tremendously. This treatment is now standard practice.”
EORTC is a pan European, multidisciplinary clinical cancer research organization, offering an extensive clinical infrastructure to conduct large phase III trials. In this respect, EORTC participates in the steering committee of the Prostate Cancer Consortium in Europe (PEACE), which was established in 2013 to facilitate large academic clinical trials for prostate cancer (specifically phase III studies) in Europe.
With national organizations and EORTC, PEACE Consortium initiated two large phase III clinical trials to answer questions about the use of two additional therapy options for prostate cancer: abiraterone and cabazitaxel. These studies, called PEACE1 (NCT01957436) and PEACE2 (NCT01952223), are the first large phase III trials to be carried out under the PEACE banner and were both launched in 2013.
EORTC-1201-GUCG-ROG – PEACE-1 is a prospective randomized phase III study of androgen deprivation therapy with or without local radiotherapy and with or without abiraterone acetate and prednisone in patients with metastatic hormone-naive prostate cancer. It plans to recruit 916 patients, and it had already accrued more than 300 patients.
PEACE-2 is a randomized phase III study of cabazitaxel and radiotherapy directed to pelvic lymph nodes in patients with localized prostate cancer and at least two high-risk features of relapse after being treated with radiotherapy and androgen deprivation therapy for 3 years. It plans to recruit 1,048 patients.
EORTC-1333-GUCG – PEACE III is a randomized multicentre phase III trial comparing enzalutamide alone versus a combination of radium-223 and enzalutamide in asymptomatic or symptomatic patients with castration-resistant prostate cancer that has metastasized to the bones. To fit the strategy of the EORTC Genito-Urinary Cancers Group, research on imaging of bone metastases will be undertaken and, in addition, the value of post-progression response and second progression patterns as surrogate factors for drug combination registration will be studied. It plans to recruit 560 patients.
Despite the prevalence of the prostate cancer, there is often a stigma associated with the cancer, preventing men to get check-ups, identifying symptoms and speaking about the health of their prostate. With the advances in prostate cancer treatment, the overall survival of male patients is improving, however the fact that people are uncomfortable and reluctant to talk openly about the disease, could result in the loss of life. The common misconception that metastatic prostate cancer is untreatable is further inhibiting men from coming forward and being tested. Early detection and available treatments can effectively prolong life and increase quality of life for men with advanced disease. Movember Foundation focuses on prostate cancer to bring more awareness to this issue. For more information about the Movember Foundation, please go to www.movember.com
For more information about ongoing EORTC GU trials, please go to Clinical Trial Database.
(1) Prostate cancer: Recommendations to lower the risk and mortality rate of the most frequent cancer in men, EAU white paper.
(2) Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Lancet. 2002 Jul 13;360(9327):103-6.
(3) Duration of androgen suppression in the treatment of prostate cancer. Bolla M, de Reijke TM, Van Tienhoven G, Van den Bergh AC, Oddens J, Poortmans PM, Gez E, Kil P, Akdas A, Soete G, Kariakine O, van der Steen-Banasik EM, Musat E, Piérart M, Mauer ME, Collette L; EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group. N Engl J Med. 2009 Jun 11;360(24):2516-27. doi: 10.1056/NEJMoa0810095.
(4) Immediate or deferred androgen deprivation for patients with prostate cancer not suitable for local treatment with curative intent: European Organisation for Research and Treatment of Cancer (EORTC) Trial 30891. Studer UE, Whelan P, Albrecht W, Casselman J, de Reijke T, Hauri D, Loidl W, Isorna S, Sundaram SK, Debois M, Collette L. J Clin Oncol. 2006 Apr 20;24(12):1868-76.