SAN DIEGO, CA USA (Press Release) - May 6, 2013 -
Urges providers to incorporate patient treatment goals, preferences and personal goals
Metastatic, castration-resistant prostate cancer (mCRPC) remains an incurable disease, but new treatments –including immunotherapeutic, chemotherapeutic agents, anti-androgens and androgen synthesis inhibitors – may improve outcomes in certain patients, according to a new clinical guideline released today by the American Urological Association (AUA) during its 2013 Annual Meeting in San Diego, CA.
Over the past decade, a number of new treatments have emerged to improve survival in men whose prostate cancer is not responsive to traditional androgen deprivation therapy. However, clinical decision-making for patients with mCRPC is complex, due to the multiple options available for treatment and proper sequencing of these medications in patients. The guideline provides a sound, evidence-based rationale for the treatment of CRPC, but urges practitioners to use the guidance in conjunction with current literature and the individual patient’s treatment goals.
Guidelines statements are specific to six different index patients, identified based on symptoms, performance status, the presence or absence of metastases and whether or not docetaxel has been administered.
Index Patient 1: Asymptomatic, non-metastatic CRPC
- Clinicians should recommend observation with continued androgen deprivation to patients with non-metastatic CRPC.
- Clinicians may offer treatment with first-generation anti-androgens (flutamide, bicalutamide and nilutamide) or first-generation androgen synthesis inhibitors (ketoconazole plus steroid) to select with non-metastatic CRPC who are unwilling to accept observation.
- Clinicians should not offer systemic chemotherapy or immunotherapy to patients with non-metastatic CRPC outside the context of a clinical trial.
Index Patient 2: Asymptomatic or minimally symptomatic, mCRPC without prior docetaxel chemotherapy
- Clinicians should offer abiraterone plus prednisone, docetaxel or sipuleucel-T to patients with asymptomatic or minimally symptomatic mCRPC with good performance status and no prior docetaxel chemotherapy.
- Clinicians may offer first-generation anti-androgen therapy, ketoconazole plus steroid or observation to patients with asymptomatic or minimally symptomatic mCRPC with good performance status and no prior docetaxel chemotherapy who do not want or cannot have one of the standard therapies.
Index Patient 3: Symptomatic, mCRPC with good performance status and no prior chemotherapy
- Clinicians should offer docetaxel to patients with symptomatic, mCRPC with good performance status and no prior docetaxel chemotherapy.
- Clinicians may offer abiraterone plus prednisone to patients with symptomatic, mCRPC with good performance status and no prior docetaxel chemotherapy.
- Clinicians may offer ketoconazole plus steroid, mitoxantrone or radionuclide therapy to patients with symptomatic mCRPC with good performance status and no prior docetaxel chemotherapy who do not want or cannot have one of the standard therapies.
- Clinicians should not offer treatment with either estramustine or sipuleucel-T to patients with symptomatic mCRPC with good performance status and no prior docetaxel chemotherapy.
Index Patient 4: Symptomatic, mCRPC with poor performance status and no prior docetaxel chemotherapy
- Clinicians may offer treatment with abiraterone plus prednisone to patients with symptomatic mCRPC with poor performance status and no prior docetaxel chemotherapy.
- Clinicians may offer treatment with ketoconazole plus steroid or radionuclide therapy to patients with symptomatic mCRPC with poor performance status and no prior docetaxel chemotherapy who are unable or unwilling to receive abiraterone plus prednisone.
- Clinicians may offer docetaxel or mitoxantrone chemotherapy to patients with symptomatic mCRPC with poor performance status and no prior docetaxel chemotherapy in select cases, specifically when the performance status is directly related to the cancer.
- Clinicians should not offer sipuleucel-T to patients with symptomatic mCRPC with poor performance status and no prior docetaxel chemotherapy.
Patient 5: Symptomatic, mCRPC with good performance status and prior doxetaxel chemotherapy
- Clinicians should offer treatment with abiraterone plus prednisone, cabazitaxel or enzalutamide to patients with mCRPC with good performance status who have received prior docetaxel chemotherapy. If the patient received abiraterone plus prednisone prior to docetaxel chemotherapy, they should be offered cabazitaxel or enzalutamide.
- Clinicians may offer ketoconazole plus steroid to patients with mCRPC with good performance status who received prior docetaxel if abiraterone plus prednisone, cabazitaxel or enzalutamide is unavailable.
- Clinicians may offer retreatment with docetaxel to patients with mCRPC with good performance status who were benefitting at the time of discontinuation (due to reversible side effects) of docetaxel treatment.
Index Patient 6: Symptomatic, mCRPC with poor performance status and prior docetaxel chemotherapy
- Clinicians should offer palliative care to patients with mCRPC with poor performance status who received prior docetaxel chemotherapy. Alternatively, for selected patients, clinicians may offer treatment with abiraterone plus prednisone, enzalutamide, ketoconazole plus steroid or radionuclide therapy.
- Clinicians should not offer systemic chemotherapy or immunotherapy to patients with mCRPC with poor performance status who received prior docetaxel chemotherapy.
Because the most common site for prostate cancer metastasis is the skeletal system, the guideline also makes key statements regarding bone health in patients with mCRPC:
- Clinicians should offer preventative treatment (e.g., supplemental calcium, vitamin D) for fractures and skeletal-related events to CRPC patients.
- Clinicians may choose either denosumab or zoledronic acid when selecting a preventative treatment for skeletal-related events for mCRPC patients with bony metastases.
“Prostate cancer death are typically the result of mCRPC, a painful disease for which, until recently, the only treatments available were palliative,” said Dr. Michael Cookson, who chaired the panel that developed the guideline. “In recent years, a number of new treatments and therapeutic agents have entered the market that have been shown to minimize adverse effects and pain and prolong survival in some patients, but the fact remains that mCRPC is the terminal stage of prostate cancer.
“As research continues in this area, we are hopeful that new developments will lead us closer to preventing the development of mCRPC.”
NOTE TO REPORTERS: Expert spokespeople are available to discuss the AUA’s new Guideline on Castration Resistant Prostate Cancer. Please contact the Communications Office at 410-689-3932 for more information or to arrange an interview. About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 19,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 19,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy.
American Urological Association
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