eUpdate – Cancer of the Prostate Treatment Recommendations
Published: 2 April 2019. Authors: ESMO Guidelines Committee
Note: Other eUpdates may have been published for these guidelines. All currently valid eUpdates can be accessed from the page displaying the full guidelines on this topic
Clinical Practice Guidelines
This update refers to the Cancer of the prostate: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Parker C., Gillessen S., Heidenreich A. et al. Ann Oncol 2015; 26 (Suppl 5): v69-v77.
Management of advanced/metastatic disease
Two phase III trials have studied the addition of prostate radiotherapy (RT) to standard systemic treatment in men with newly diagnosed metastatic disease. The STAMPEDE trial included > 2000 patients and showed that RT to the prostate did not improve overall survival (OS) for unselected patients . However, a pre-specified subgroup analysis showed that RT did improve OS (from 73% to 81% at 3 years) in those with a low metastatic burden (defined according to the CHAARTED criteria). The HORRAD trial included 432 patients and the results were consistent with STAMPEDE: there was no OS benefit in unselected patients . In both trials, standard systemic treatment was androgen deprivation therapy (ADT) alone for the majority of patients. Meta-analysis of these two trials found that prostate RT improved 3-year OS by 7% for men with less than five metastases on baseline bone scan .
- In patients with newly diagnosed low burden metastatic prostate cancer, prostate RT is recommended in addition to standard systemic treatment as one treatment option [I, A].
Treatment of castrate-resistant prostate cancer
In ERA 223, a double-blind, placebo-controlled phase III trial, asymptomatic and mildly symptomatic patients with progressive chemotherapy-naive castration-resistant prostate cancer (CRPC) and bone metastases were randomised to receive abiraterone acetate plus prednisone or prednisolone (AAP) plus radium-223 or AAP and placebo. The addition of radium-223 did not improve symptomatic skeletal-related event (SRE)-free survival but was associated with increased bone fractures. The majority of these bone fractures seemed to be osteoporotic .
The combination of AAP and radium-223 should not be given to patients with metastatic CRPC (mCRPC) [I, A].
Bone protective agents should be used in men with mCRPC to prevent fractures [II, A].
- Parker CC, James ND, Brawley CD, et al. Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): randomised controlled phase 3 trial. Lancet 2018; 392: 2353-2366.
- Boevé LMS, Hulshof MCCM, Vis AN et al. Effect on Survival of Androgen Deprivation Therapy Alone Compared to Androgen Deprivation Therapy Combined with Concurrent Radiation Therapy to the Prostate in Patients with Primary Bone Metastatic Prostate Cancer in a Prospective Randomised Clinical Trial: Data from the HORRAD Trial. Eur Urol 2019; 75: 410-418.
- Burdett S, Boevé LM, Ingleby FC et al. Prostate Radiotherapy for Metastatic Hormone-sensitive Prostate Cancer: A STOPCAP Systematic Review and Meta-analysis. Eur Urol 2019 Feb 27. pii: S0302-2838(19)30111-3. doi: 10.1016/j.eururo.2019.02.003. [Epub ahead of print].
- Smith M et al. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 2019; 20: 408-419.