Patient Profiles

View hypothetical treatment scenarios

Select from the 3 tabs below to view profiles of patients with non-metastatic CRPC. These are hypothetical patient scenarios and model portrayals.

ray profile

Not an actual patient.

RAY

Short PSA Doubling Time
(≤6 months)

 

OWEN

Asymptomatic
(ECOG PS=0)

 

JAVIER

Pelvic Lymph Node-Positive
(N1) Disease

Clinical characteristics

  PSA :   7.4 ng/mL

  PSA doubling time:   5 months

  Gleason score at initial diagnosis:   9 (5+4)*

Medical history

  • Initially diagnosed with prostate cancer 4 years ago; received external beam radiation therapy (EBRT)
  • Refused ADT as part of initial EBRT
  • Experienced a biochemical recurrence; started ADT 18 months ago
  • Has a rapidly rising PSA while on continuous ADT with a serum testosterone level <50 ng/dL; newly diagnosed with CRPC and no radiographic evidence of metastases

Not an actual patient.

Current prostate cancer therapy | GnRH analog |

Treatment considerations

  • In men with non-metastatic CRPC, a faster PSA doubling time has been linked to a shorter time to metastasis and decreased survival1
  • Ray and his family are worried about his rapidly rising PSA. They are concerned about what it may mean about his prostate cancer

 

In the SPARTAN study:

ERLEADA® + ADT improved median metastasis-free survival (MFS) by    YEARS (24.3 months) vs placebo + ADT2
(40.5 months vs 16.2 months; HR=0.28; 95% CI: 0.23, 0.35; P<0.0001)

Consistent results in metastasis-free survival (MFS) were observed with ERLEADA® + ADT across patient subgroups, including those with a PSA doubling time ≤6 months or >6 months2

For your patients like RAY who have non-metastatic CRPC:

Prescribe ERLEADA®

Learn more about the SPARTAN study design and efficacy results

 

ERLEADA® is indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer

Patients with non-metastatic CRPC in the SPARTAN study:

  • On ADT
  • With a rapidly rising PSA
  • And no distant metastases detectable by conventional imaging§

PSA doubling time ≤10 months.

§In the SPARTAN study, conventional imaging (technetium-99m bone scans and CT scans) was used to confirm that patients were non-metastatic at screening for inclusion. Patients with pelvic lymph nodes <2 cm in short axis (N1) located below the iliac bifurcation at screening were allowed in the study.3

View hypothetical treatment scenarios

RAY

Short PSA Doubling Time
(≤6 months)

OWEN

Asymptomatic (ECOG PS=0)

JAVIER

Pelvic Lymph Node-Positive (N1) Disease

*Equivalent to Gleason grade group 5.

Study Design: SPARTAN was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of patients with non-metastatic CRPC (N=1207). Patients had a PSA doubling time ≤10 months and serum testosterone levels <50 ng/dL. All patients in the SPARTAN trial received a concomitant GnRH analog or had a bilateral orchiectomy. All patients enrolled were confirmed to be non-metastatic by blinded central imaging review. Patients with a history of seizure, predisposing factors for seizure, or receiving drugs known to decrease the seizure threshold or to induce seizure were excluded. Patients were randomized 2:1 to receive ERLEADA® 240 mg orally once daily + ADT or placebo orally once daily + ADT. The primary endpoint was metastasis-free survival (MFS), defined as the time from randomization to the time of first evidence of blinded independent central review-confirmed distant metastasis, defined as new bone or soft tissue lesions or enlarged lymph nodes above the iliac bifurcation, or death due to any cause, whichever occurred first.2-4

Learn more about the SPARTAN study design

ADT = androgen deprivation therapy; CI = confidence interval; CRPC = castration-resistant prostate cancer; CT = computed tomography; GnRH = gonadotropin-releasing hormone; HR = hazard ratio; nmCRPC = non-metastatic castration-resistant prostate cancer; PSA = prostate-specific antigen; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509.

 

References

 

RAY

Short PSA Doubling Time
(≤6 months)

owen profile

Not an actual patient.

OWEN

Asymptomatic
(ECOG PS=0)

 

JAVIER

Pelvic Lymph Node-Positive
(N1) Disease

Clinical characteristics

  PSA :   3.2 ng/mL

  PSA doubling time:   9 months

  Gleason score at initial diagnosis:   8 (4+4)

Medical history

  • Initially diagnosed with prostate cancer 10 years ago; underwent radical prostatectomy
  • Experienced a biochemical recurrence; started ADT 4 years ago
  • He now has a rising PSA while on continuous ADT with a serum testosterone level <50 ng/dL; newly diagnosed with CRPC and no radiographic evidence of metastases

Not an actual patient.

Current prostate cancer therapy | GnRH analog|

Treatment considerations

  • The development of bone metastases can lead to symptoms1
  • Owen is concerned about developing metastases and symptoms. His wife is concerned that something bad may be going on with his prostate cancer

In the SPARTAN study:

ERLEADA® + ADT improved median metastasis-free survival (MFS) by    YEARS (24.3 months) vs placebo + ADT2
(40.5 months vs 16.2 months; HR=0.28; 95% CI: 0.23, 0.35; P<0.0001)

Secondary endpoint:

The metastasis-free survival (MFS) outcome was supported by a statistically significant improvement in time to symptomatic progression2

Time to symptomatic progression was defined as the time from randomization to documentation of any of the following (whichever occurred earlier)3,4

  • Development of a skeletal-related event: pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone
  • Pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anticancer therapy
  • Development of clinically significant symptoms due to locoregional tumor progression requiring surgical intervention or radiation therapy

Examples of symptomatic progression
evaluated in the SPARTAN study:

spinal-cord

Spinal cord
compression

surgical-need

The need for
surgical intervention

radiation

The need for
radiation therapy

For your patients with non-metastatic CRPC like
OWEN : Prescribe ERLEADA®

Learn more about the SPARTAN study design and efficacy results

 

ERLEADA® is indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer

Patients with non-metastatic CRPC in the SPARTAN study:

  • On ADT
  • With a rapidly rising PSA§
  • And no distant metastases detectable by conventional imaging

§PSA doubling time ≤10 months.

In the SPARTAN study, conventional imaging (technetium-99m bone scans and CT scans) was used to confirm that patients were non-metastatic at screening for inclusion. Patients with pelvic lymph nodes <2 cm in short axis (N1) located below the iliac bifurcation at screening were allowed in the study.3

View hypothetical treatment scenarios

RAY

Short PSA Doubling Time
(≤6 months)

OWEN

Asymptomatic (ECOG PS=0)

JAVIER

Pelvic Lymph Node-Positive (N1) Disease

*In the SPARTAN study, all patients had an ECOG PS score of 0 or 1 at study entry.

Equivalent to Gleason grade group 4.

Study Design: SPARTAN was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of patients with non-metastatic CRPC (N=1207). Patients had a PSA doubling time ≤10 months and serum testosterone levels <50 ng/dL. All patients in the SPARTAN trial received a concomitant GnRH analog or had a bilateral orchiectomy. All patients enrolled were confirmed to be non-metastatic by blinded central imaging review. Patients with a history of seizure, predisposing factors for seizure, or receiving drugs known to decrease the seizure threshold or to induce seizure were excluded. Patients were randomized 2:1 to receive ERLEADA® 240 mg orally once daily + ADT or placebo orally once daily + ADT. The primary endpoint was metastasis-free survival (MFS), defined as the time from randomization to the time of first evidence of blinded independent central review-confirmed distant metastasis, defined as new bone or soft tissue lesions or enlarged lymph nodes above the iliac bifurcation, or death due to any cause, whichever occurred first.2-4

Learn more about the SPARTAN study design

ADT = androgen deprivation therapy; CI = confidence interval; CRPC = castration-resistant prostate cancer; CT = computed tomography; ECOG PS = Eastern Cooperative Oncology Group Performance Status; GnRH = gonadotropin-releasing hormone; HR = hazard ratio; nmCRPC = non-metastatic castration-resistant prostate cancer; PSA = prostate-specific antigen; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509.

 

References

 

RAY

Short PSA Doubling Time
(≤6 months)

 

OWEN

Asymptomatic
(ECOG PS=0)

ray profile

Not an actual patient.

JAVIER

Pelvic Lymph Node-Positive
(N1) Disease

Clinical characteristics

  PSA :   5.6 ng/mL

  PSA doubling time:   10 months

  Gleason score at initial diagnosis:   7 (4+3)*

Medical history

  • Initially diagnosed with prostate cancer 5 years ago; received external beam radiation therapy with concomitant ADT for a total of 6 months
  • After experiencing a biochemical recurrence, restarted ADT 2 years ago
  • Has a rising PSA while on continuous ADT with a serum testosterone level <50 ng/dL; newly diagnosed with CRPC
  • Imaging revealed 2 positive pelvic lymph nodes (1.5 cm in short axis) but no radiographic evidence of distant metastases

Not an actual patient.

Current prostate cancer therapy | GnRH analog|

Treatment considerations

  • Javier is concerned that his prostate cancer will soon spread beyond his lymph nodes
  • He has asked what can be done to stop his cancer from getting worse

In the SPARTAN study:

ERLEADA® + ADT improved median metastasis-free survival (MFS) by    YEARS (24.3 months) vs placebo + ADT1
(40.5 months vs 16.2 months; HR=0.28; 95% CI: 0.23, 0.35; P<0.0001)

Consistent results in metastasis-free survival (MFS) were observed with ERLEADA® + ADT across patient subgroups, including those with (N1) or without (N0) locoregional disease, those with a PSA doubling time ≤6 months or >6 months, and those who did or did not previously receive a bone-sparing agent1

For your patients like JAVIER who have non-metastatic CRPC:

Prescribe ERLEADA®

Learn more about the SPARTAN study design and efficacy results

 

ERLEADA® is indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer

Patients with non-metastatic CRPC in the SPARTAN study:

  • On ADT
  • With a rapidly rising PSA§
  • And no distant metastases detectable by conventional imaging

§PSA doubling time ≤10 months.

In the SPARTAN study, conventional imaging (technetium-99m bone scans and CT scans) was used to confirm that patients were non-metastatic at screening for inclusion. Patients with pelvic lymph nodes <2 cm in short axis (N1) located below the iliac bifurcation at screening were allowed in the study.2

View hypothetical treatment scenarios

RAY

Short PSA Doubling Time
(≤6 months)

OWEN

Asymptomatic (ECOG PS=0)

JAVIER

Pelvic Lymph Node-Positive (N1) Disease

Equivalent to Gleason grade group 3.

Study Design: SPARTAN was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of patients with non-metastatic CRPC (N=1207). Patients had a PSA doubling time ≤10 months and serum testosterone levels <50 ng/dL. All patients in the SPARTAN trial received a concomitant GnRH analog or had a bilateral orchiectomy. All patients enrolled were confirmed to be non-metastatic by blinded central imaging review. Patients with a history of seizure, predisposing factors for seizure, or receiving drugs known to decrease the seizure threshold or to induce seizure were excluded. Patients were randomized 2:1 to receive ERLEADA® 240 mg orally once daily + ADT or placebo orally once daily + ADT. The primary endpoint was metastasis-free survival (MFS), defined as the time from randomization to the time of first evidence of blinded independent central review-confirmed distant metastasis, defined as new bone or soft tissue lesions or enlarged lymph nodes above the iliac bifurcation, or death due to any cause, whichever occurred first.1-3

Learn more about the SPARTAN study design

Patients with pelvic lymph nodes <2 cm in short axis (N1) located below the iliac bifurcation at screening were allowed in the SPARTAN study. At baseline, 16% of patients in SPARTAN had local or regional nodal disease (N1).2

ADT = androgen deprivation therapy; CI = confidence interval; CRPC = castration-resistant prostate cancer; CT = computed tomography; GnRH = gonadotropin-releasing hormone; HR = hazard ratio; nmCRPC = non-metastatic castration-resistant prostate cancer; PSA = prostate-specific antigen; SPARTAN = Selective Prostate Androgen Receptor Targeting with ARN-509.

 

References