Patient Profiles in nmCRPC

View hypothetical treatment scenarios

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

A headshot of a happy older black man, wearing a gray suit with purple shirt

A headshot of a happy older black man, wearing a gray suit with purple shirt

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 nmCRPC, 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

A photo of an older black man leaning on a wall, wearing a gray suit with purple shirt

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 nmCRPC:

Prescribe ERLEADA®

Learn more about the SPARTAN study design and efficacy results

 

In the SPARTAN study, ERLEADA® was evaluated in patients with nmCRPC

Patients with nmCRPC 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 Grade Group 5.4

Study Design: SPARTAN was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of patients with nmCRPC (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.2,3,5

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)

A headshot of a happy older white man, wearing a black hat, denim shirt, and suspenders

A headshot of a happy older white man, wearing a black hat, denim shirt, and suspenders

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

An photo of an older white man leaning on a wall, wearing a black hat, denim shit, slacks and suspenders

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:

A circular x-ray, showing the spinal cord being pinched by a lump

Spinal cord
compression

A circular x-ray, showing a replaced hip joint

The need for
surgical intervention

A circular photo of a M R I machine

The need for
radiation therapy

For your patients with nmCRPC like
OWEN : Prescribe ERLEADA®

Learn more about the SPARTAN study design and efficacy results

 

In the SPARTAN study, ERLEADA® was evaluated in patients with nmCRPC

Patients with nmCRPC 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 SPARTAN, all patients had an ECOG PS score of 0 or 1 at study entry.

Equivalent to Grade Group 4.5

Study Design: SPARTAN was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of patients with nmCRPC (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)

A headshot of a happy older Hispanic man, wearing a blue sweater with blue shirt

A headshot of a happy older Hispanic man, wearing a blue sweater with blue shirt

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

A photo of an older Hispanic man, wearing a blue sweater with blue shirt

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 nmCRPC:

Prescribe ERLEADA®

Learn more about the SPARTAN study design and efficacy results

 

In the SPARTAN study, ERLEADA® was evaluated in patients with nmCRPC

Patients with nmCRPC 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 Grade Group 3.3

Study Design: SPARTAN was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of patients with nmCRPC (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.1,2,4

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; 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