ESMO Guidelines for Prostate Cancer
Management Exam Practice Questions
and Answers
What did indirect Bayesian comparisons suggest about abiraterone compared to
docetaxel? - Answer-Abiraterone may provide a greater survival and quality of life
benefit than docetaxel.
What factors should be considered when deciding between abiraterone, apalutamide,
enzalutamide, or docetaxel? - Answer-Cost, access to treatment, toxicity profiles,
duration of treatment, comorbidities, and patient preferences.
What was the primary focus of the HORRAD trial? - Answer-To compare lifelong ADT
alone versus ADT in combination with RT to the primary tumor for mHNPC.
What were the results of the HORRAD trial regarding PSA progression and overall
survival? - Answer-RT improved time to PSA progression (HR 0.78) but did not improve
overall survival (HR 0.90).
What was the treatment protocol for the STAMPEDE trial involving docetaxel? -
Answer-Docetaxel was allowed in both arms, with RT to the primary starting 3-4 weeks
after the last docetaxel dose.
What were the findings of the STAMPEDE trial regarding failure-free survival and
overall survival? - Answer-RT improved failure-free survival (HR 0.76) but did not
significantly improve overall survival (HR 0.92).
What is the CHAARTED criteria used for in the context of the STAMPEDE trial? -
Answer-To define the low-volume subgroup that showed significant benefit in failure-
free survival.
What was the primary endpoint of the PROSPER trial evaluating enzalutamide? -
Answer-Median metastasis-free survival.
How did enzalutamide perform compared to placebo in the PROSPER trial? - Answer-
Enzalutamide showed superior results with a median metastasis-free survival of 36.6
months versus 14.7 months (HR 0.29).
What were the key secondary endpoints evaluated in the PROSPER trial? - Answer-
Median time to PSA progression and time to subsequent antineoplastic therapy.
,What were the common side effects reported in the enzalutamide group of the
PROSPER trial? - Answer-Fatigue, hypertension, adverse cardiovascular events, and
mental-impairment disorders.
What was the focus of the ARAMIS trial regarding darolutamide? - Answer-To evaluate
its effectiveness in men with high-risk M0 CRPC.
What was the median metastasis-free survival for darolutamide compared to placebo in
the ARAMIS trial? - Answer-Darolutamide had a median of 40.4 months versus 18.4
months for placebo (HR 0.41).
What were the reported adverse events for darolutamide compared to placebo? -
Answer-Grade 3 or 4 adverse events were reported in 19.5% for placebo and 24.7% for
darolutamide.
What is the ESMO-MCBS score for apalutamide, darolutamide, and enzalutamide? -
Answer-All three have an ESMO-MCBS v1.1 score of 3.
What treatment options are recommended for men with M0 CRPC at high risk of
disease progression? - Answer-Apalutamide, darolutamide, or enzalutamide.
What benefits do bicalutamide and low-dose corticosteroids provide for men with
metastatic CRPC? - Answer-They show benefits in PSA and symptomatic responses,
but no randomized trials have demonstrated a benefit in overall survival.
What were the findings regarding 223Ra in patients with progressive bone-predominant
mCRPC? - Answer-223Ra significantly increased overall survival (HR 0.70) and time to
first symptomatic skeletal event (HR 0.66) compared with placebo.
What side effects were associated with 223Ra treatment? - Answer-Thrombocytopenia
(3% G3) and diarrhea (2% G3).
What was the ESMO-MCBS score for 223Ra in the trial? - Answer-5
What was the incidence of fractures in patients receiving 223Ra compared to placebo? -
Answer-28.6% for 223Ra versus 11.4% for placebo.
What are the restrictions for using 223Ra according to the European Medicines
Agency? - Answer-It is restricted to patients who have received at least two lines of
systemic treatment for CRPC or are ineligible for these therapies.
Is the combination of 223Ra with abiraterone acetate and prednisone permitted? -
Answer-No, it is not permitted.
,What was the improvement in overall survival (OS) with cabazitaxel compared to
mitoxantrone in the TROPIC trial? - Answer-Cabazitaxel improved OS with a hazard
ratio (HR) of 0.70.
What were the main side effects associated with cabazitaxel? - Answer-Increased
myelosuppression, including febrile neutropenia and diarrhea.
How did abiraterone plus prednisone perform compared to placebo in the COU-301
study? - Answer-It improved OS with a hazard ratio (HR) of 0.74.
What was the outcome of enzalutamide compared to placebo in the AFFIRM trial? -
Answer-Enzalutamide improved OS with a hazard ratio (HR) of 0.63.
What is known about cross-resistance between abiraterone and enzalutamide? -
Answer-There is strong evidence suggesting cross-resistance between the two agents.
What were the median OS results for cabazitaxel versus a second AR inhibitor in the
CARD trial? - Answer-Median OS was 13.6 months with cabazitaxel and 11.0 months
with the second AR inhibitor.
What factors influence sequencing decisions in mCRPC treatment? - Answer-
Distribution, extent and pace of disease, comorbidities, previous treatments, patient
preferences, and drug availability.
What were the results of the COU-AA-302 trial regarding abiraterone acetate? -
Answer-Abiraterone significantly improved OS with a hazard ratio (HR) of 0.79.
What side effects were noted with abiraterone acetate? - Answer-Hypokalemia,
hypertension, edema, and cardiac events.
What was the finding regarding low-dose abiraterone taken with food? - Answer-It
appeared to have similar activity to standard dose abiraterone under fasting conditions,
but this has not been tested in phase III trials.
What were the results of the PREVAIL trial for enzalutamide? - Answer-Enzalutamide
was superior to placebo in terms of OS with a hazard ratio (HR) of 0.71.
What were the common adverse events associated with enzalutamide? - Answer-
Fatigue/asthenia and hypertension.
What was the outcome of the TAX-327 trial regarding docetaxel? - Answer-Docetaxel
significantly increased OS compared to mitoxantrone with a hazard ratio (HR) of 0.76.
What was the finding of the SWOG-9916 trial regarding docetaxel? - Answer-The
combination of docetaxel, estramustine, and prednisone was superior to mitoxantrone
plus prednisone in prolonging OS.
, What are the recommended treatments for asymptomatic/mildly symptomatic men with
ChT-naive mCRPC? - Answer-Abiraterone or enzalutamide.
What is recommended for men with mCRPC? - Answer-Docetaxel.
What are the recommended options for patients with mCRPC in the post-docetaxel
setting? - Answer-Abiraterone, enzalutamide, and cabazitaxel.
What is the recommended treatment for patients with bone metastases from CRPC at
risk for clinically significant skeletal-related events (SREs)? - Answer-Treatment with
radium-223 (223Ra) is recommended, along with bisphosphonate or denosumab.
What does the ALSYMPCA trial demonstrate regarding radium-223? - Answer-The trial
showed that radium-223 is effective for men with bone-predominant, symptomatic
mCRPC without visceral metastases.
Is radium-223 recommended in combination with abiraterone and prednisolone? -
Answer-No, radium-223 is not recommended in combination with abiraterone and
prednisolone.
What is the recommendation regarding the use of a second AR inhibitor after
enzalutamide or vice versa? - Answer-The use of a second AR inhibitor is not
recommended.
What is the significance of germline and somatic mutations in prostate cancer
management? - Answer-They may predict response to platinum-based chemotherapy
and PARP inhibitors.
Which genes are potential predictors of response to platinum-based chemotherapy and
PARP inhibitors? - Answer-BRCA2 and other genes involved in the homologous
recombination pathway.
What does the PROFOUND trial test in patients with mCRPC? - Answer-It tests olaparib
versus a second AR axis inhibitor in patients with alterations in genes related to DNA
damage repair (DDR).
What were the results of the PROFOUND trial regarding olaparib? - Answer-Olaparib
improved radiographic progression-free survival (rPFS) and overall survival (OS) in
patients with alterations in BRCA1, BRCA2, or ATM.
What is recommended regarding tissue-based molecular assays in localized prostate
cancer? - Answer-They may be used in conjunction with clinicopathological factors for
treatment decision making.
Management Exam Practice Questions
and Answers
What did indirect Bayesian comparisons suggest about abiraterone compared to
docetaxel? - Answer-Abiraterone may provide a greater survival and quality of life
benefit than docetaxel.
What factors should be considered when deciding between abiraterone, apalutamide,
enzalutamide, or docetaxel? - Answer-Cost, access to treatment, toxicity profiles,
duration of treatment, comorbidities, and patient preferences.
What was the primary focus of the HORRAD trial? - Answer-To compare lifelong ADT
alone versus ADT in combination with RT to the primary tumor for mHNPC.
What were the results of the HORRAD trial regarding PSA progression and overall
survival? - Answer-RT improved time to PSA progression (HR 0.78) but did not improve
overall survival (HR 0.90).
What was the treatment protocol for the STAMPEDE trial involving docetaxel? -
Answer-Docetaxel was allowed in both arms, with RT to the primary starting 3-4 weeks
after the last docetaxel dose.
What were the findings of the STAMPEDE trial regarding failure-free survival and
overall survival? - Answer-RT improved failure-free survival (HR 0.76) but did not
significantly improve overall survival (HR 0.92).
What is the CHAARTED criteria used for in the context of the STAMPEDE trial? -
Answer-To define the low-volume subgroup that showed significant benefit in failure-
free survival.
What was the primary endpoint of the PROSPER trial evaluating enzalutamide? -
Answer-Median metastasis-free survival.
How did enzalutamide perform compared to placebo in the PROSPER trial? - Answer-
Enzalutamide showed superior results with a median metastasis-free survival of 36.6
months versus 14.7 months (HR 0.29).
What were the key secondary endpoints evaluated in the PROSPER trial? - Answer-
Median time to PSA progression and time to subsequent antineoplastic therapy.
,What were the common side effects reported in the enzalutamide group of the
PROSPER trial? - Answer-Fatigue, hypertension, adverse cardiovascular events, and
mental-impairment disorders.
What was the focus of the ARAMIS trial regarding darolutamide? - Answer-To evaluate
its effectiveness in men with high-risk M0 CRPC.
What was the median metastasis-free survival for darolutamide compared to placebo in
the ARAMIS trial? - Answer-Darolutamide had a median of 40.4 months versus 18.4
months for placebo (HR 0.41).
What were the reported adverse events for darolutamide compared to placebo? -
Answer-Grade 3 or 4 adverse events were reported in 19.5% for placebo and 24.7% for
darolutamide.
What is the ESMO-MCBS score for apalutamide, darolutamide, and enzalutamide? -
Answer-All three have an ESMO-MCBS v1.1 score of 3.
What treatment options are recommended for men with M0 CRPC at high risk of
disease progression? - Answer-Apalutamide, darolutamide, or enzalutamide.
What benefits do bicalutamide and low-dose corticosteroids provide for men with
metastatic CRPC? - Answer-They show benefits in PSA and symptomatic responses,
but no randomized trials have demonstrated a benefit in overall survival.
What were the findings regarding 223Ra in patients with progressive bone-predominant
mCRPC? - Answer-223Ra significantly increased overall survival (HR 0.70) and time to
first symptomatic skeletal event (HR 0.66) compared with placebo.
What side effects were associated with 223Ra treatment? - Answer-Thrombocytopenia
(3% G3) and diarrhea (2% G3).
What was the ESMO-MCBS score for 223Ra in the trial? - Answer-5
What was the incidence of fractures in patients receiving 223Ra compared to placebo? -
Answer-28.6% for 223Ra versus 11.4% for placebo.
What are the restrictions for using 223Ra according to the European Medicines
Agency? - Answer-It is restricted to patients who have received at least two lines of
systemic treatment for CRPC or are ineligible for these therapies.
Is the combination of 223Ra with abiraterone acetate and prednisone permitted? -
Answer-No, it is not permitted.
,What was the improvement in overall survival (OS) with cabazitaxel compared to
mitoxantrone in the TROPIC trial? - Answer-Cabazitaxel improved OS with a hazard
ratio (HR) of 0.70.
What were the main side effects associated with cabazitaxel? - Answer-Increased
myelosuppression, including febrile neutropenia and diarrhea.
How did abiraterone plus prednisone perform compared to placebo in the COU-301
study? - Answer-It improved OS with a hazard ratio (HR) of 0.74.
What was the outcome of enzalutamide compared to placebo in the AFFIRM trial? -
Answer-Enzalutamide improved OS with a hazard ratio (HR) of 0.63.
What is known about cross-resistance between abiraterone and enzalutamide? -
Answer-There is strong evidence suggesting cross-resistance between the two agents.
What were the median OS results for cabazitaxel versus a second AR inhibitor in the
CARD trial? - Answer-Median OS was 13.6 months with cabazitaxel and 11.0 months
with the second AR inhibitor.
What factors influence sequencing decisions in mCRPC treatment? - Answer-
Distribution, extent and pace of disease, comorbidities, previous treatments, patient
preferences, and drug availability.
What were the results of the COU-AA-302 trial regarding abiraterone acetate? -
Answer-Abiraterone significantly improved OS with a hazard ratio (HR) of 0.79.
What side effects were noted with abiraterone acetate? - Answer-Hypokalemia,
hypertension, edema, and cardiac events.
What was the finding regarding low-dose abiraterone taken with food? - Answer-It
appeared to have similar activity to standard dose abiraterone under fasting conditions,
but this has not been tested in phase III trials.
What were the results of the PREVAIL trial for enzalutamide? - Answer-Enzalutamide
was superior to placebo in terms of OS with a hazard ratio (HR) of 0.71.
What were the common adverse events associated with enzalutamide? - Answer-
Fatigue/asthenia and hypertension.
What was the outcome of the TAX-327 trial regarding docetaxel? - Answer-Docetaxel
significantly increased OS compared to mitoxantrone with a hazard ratio (HR) of 0.76.
What was the finding of the SWOG-9916 trial regarding docetaxel? - Answer-The
combination of docetaxel, estramustine, and prednisone was superior to mitoxantrone
plus prednisone in prolonging OS.
, What are the recommended treatments for asymptomatic/mildly symptomatic men with
ChT-naive mCRPC? - Answer-Abiraterone or enzalutamide.
What is recommended for men with mCRPC? - Answer-Docetaxel.
What are the recommended options for patients with mCRPC in the post-docetaxel
setting? - Answer-Abiraterone, enzalutamide, and cabazitaxel.
What is the recommended treatment for patients with bone metastases from CRPC at
risk for clinically significant skeletal-related events (SREs)? - Answer-Treatment with
radium-223 (223Ra) is recommended, along with bisphosphonate or denosumab.
What does the ALSYMPCA trial demonstrate regarding radium-223? - Answer-The trial
showed that radium-223 is effective for men with bone-predominant, symptomatic
mCRPC without visceral metastases.
Is radium-223 recommended in combination with abiraterone and prednisolone? -
Answer-No, radium-223 is not recommended in combination with abiraterone and
prednisolone.
What is the recommendation regarding the use of a second AR inhibitor after
enzalutamide or vice versa? - Answer-The use of a second AR inhibitor is not
recommended.
What is the significance of germline and somatic mutations in prostate cancer
management? - Answer-They may predict response to platinum-based chemotherapy
and PARP inhibitors.
Which genes are potential predictors of response to platinum-based chemotherapy and
PARP inhibitors? - Answer-BRCA2 and other genes involved in the homologous
recombination pathway.
What does the PROFOUND trial test in patients with mCRPC? - Answer-It tests olaparib
versus a second AR axis inhibitor in patients with alterations in genes related to DNA
damage repair (DDR).
What were the results of the PROFOUND trial regarding olaparib? - Answer-Olaparib
improved radiographic progression-free survival (rPFS) and overall survival (OS) in
patients with alterations in BRCA1, BRCA2, or ATM.
What is recommended regarding tissue-based molecular assays in localized prostate
cancer? - Answer-They may be used in conjunction with clinicopathological factors for
treatment decision making.
