Treatments, Epidemiology, Marketed Drugs, Drugs in the Pipeline, Regulatory Events, Clinical Trials, Drug Assessment, Future Trends

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Dublin, July 14, 2021 (GLOBE NEWSWIRE) — The “Disease Analysis: Prostate Cancer” report has been added to’s to offer.

The publisher estimates that there were 1.3 million cases of prostate cancer in men aged 40 and older worldwide in 2018, and predicts that number will increase to 1.5 million cases by 2027.

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In the US, prostate cancer is the most common non-cutaneous malignancy in men and is the second leading cause of cancer death in men after lung cancer.

The overall probability of approval for a Phase I prostate cancer asset is 4.7%, and the average probability of a drug entering Phase III is 51.5%. Prostate cancer drugs take an average of 9.0 years from phase I to approval, compared to 9.6 years in the overall oncology space.

Xtandi, Pfizer’s next-generation androgen receptor inhibitor (AR), is the market leader in prostate cancer due to its proven efficacy across all prostate cancer segments and the lack of short-term generic competition. Buoyed by recent and planned expansions into additional prostate cancer segments, Xtandi will remain the leading option in this indication. Future expansion possibilities include possible use in combination with PARP inhibitors Talzenna or Rubraca in patients with metastatic castration-resistant prostate cancer (mCRPC).

Late-phase PARP inhibitors Zejula and Talzenna are also being developed in conjunction with next-generation treatments and will be part of a crowded PARP treatment space. Zejula is being tested in combination with abiraterone against abiraterone alone as first-line therapy for mCRPC patients. Similarly, Talzenna is being studied in conjunction with the physician’s choice of Xtandi or enzalutamide in mCRPC patients, also as a first-line option.

The potential synergy of the PARP inhibitors with AR modulators is promising, but a strong benefit will have to be seen to justify the frontline use of mCRPC. If approved, it is likely that these regimens will be limited to the HRD or even BRCA populations, where they will have great utility but somewhat limited commercial impact due to the relatively small prevalence of these biomarkers.

Next-generation AR inhibitors Nubeqa and Erleada have shifted the treatment paradigm to include these therapies in earlier disease segments, such as non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). Expansion into earlier segments and lines of therapy is underway. Bayer plans to expand Nubeqa’s label to include use in very high-risk localized patients and patients sensitive to metastatic hormone.

Johnson & Johnson will continue to seek to differentiate Erleada with an aggressive development plan that includes potential expansions to chemotherapy-naive mCRPC patients as part of a combination with abiraterone, as well as to the localized setting for patients treated with prostatectomy or radiation therapy.

Akt inhibitors ipatasertib and capivasertib are a potential new mechanistic addition to the prostate cancer space, but the efficacy/tolerability profile of these PI3K/Akt/mTOR pathway inhibitors may preclude approval and potential use. Ipatasertib is a pan-Akt inhibitor from Roche currently in development for asymptomatic or mildly symptomatic mCRPC patients with PTEN loss as part of a combination with abiraterone.

PTEN loss is not a standard target for this indication, but represents a significant market opportunity as it is estimated to occur in approximately 20% of primary prostate cancers and up to 50% of castration-resistant tumors. However, ipatasertib is ravaged by known class toxicities of inhibitors of the PI3K/Akt/mTOR pathway, such as diarrhea, rashes and ALT/AST elevations that can harm regulatory opportunities. AstraZeneca’s Akt inhibitor capivasertib has also shown mixed results in prostate cancer.

In the Phase I/II ProCAID study, capivasertib in combination with docetaxel did not meet the primary endpoint of improved progression-free survival in mCRPC patients. However, the combination improved overall survival in these patients, regardless of mutations in the PI3K/Akt/mTOR pathway. This has led to the initiation of the Phase III CAPItello-281 trial testing capivasertib in combination with abiraterone in de novo mHSPC with PTEN loss.

Main topics covered:



  • Definition

  • Risk Factors

  • Symptoms

  • Diagnosis

  • Prognosis

  • Patient Segmentation

  • Clinical Conditions


  • Referral Patterns

  • Localized prostate cancer

  • Locally advanced prostate cancer

  • Recurrent/progressive prostate cancer

  • Metastatic hormone-sensitive prostate cancer

  • Non-metastatic castration-resistant prostate cancer

  • Metastatic castration-resistant prostate cancer





  • Oral Orgovyx may reduce patient exposure risk to COVID-19

  • Telix takes radiopharmaceutical route to prostate cancer market

  • AstraZeneca/Merck’s Lynparza gets second-line indication for prostate cancer

  • Clovis’s rubraca is first PARP for prostate cancer, but AZ’s Lynparza is coming

  • Myovant submits first NDA for Relugolix, plans another in May

  • Trial Problems Complicate Tookad’s Path to Approval

  • Steba’s Tookad: US FDA Panel to Weigh New Endpoints, Missing Data, and Toxicities



  • Pfizer gets new commercial drug Orgovyx in deal with Myovant

  • Janssen, Xencor work together against prostate cancer

  • Diaprost obtains PSA antibody IP from Memorial Sloan Kettering


  • Sponsors by status

  • Sponsors per phase

  • Recent events




  • Xtandi will remain the best-selling therapy for the next decade

  • Abiraterone generics have largely supplanted the prescription of Zytiga

  • Johnson & Johnson will rely on Erleada to offset Zytiga’s revenue losses

  • Prescribing next-generation hormone therapies in previous treatment settings will drive market growth

  • Drugs in the pipeline targeting mCRPC patients will generate only moderate uptake



  • Orgovyx for prostate cancer (September 29, 2020)

  • AMG 160 for prostate cancer (September 21, 2020)

  • Ipatasertib for Prostate Cancer (September 20, 2020)

  • Ipatasertib for prostate cancer (June 18, 2020)

  • Capivasertib for prostate cancer (May 30, 2020)

  • HPN424 for prostate cancer (May 29, 2020)

  • Orgovyx for prostate cancer (May 29, 2020)

  • Lutetium 177Lu-PSMA-617 for prostate cancer (May 13, 2020)

  • Tookad for prostate cancer (February 26, 2020)

  • Tookad for prostate cancer (February 24, 2020)

  • Multiple drugs for prostate cancer (February 13, 2020)

  • Cabometyx/Cometriq for prostate cancer (February 10, 2020)





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