Urothelial carcinoma (UC) and prostate cancer (PC) are the most common malignancy of the urinary system. The upper tract UC (UTUC) arising from renal pelvis and ureter accounts for only 5~10% of all UCs; however, the incidence of UTUC markedly increases to 40% of the UCs in Taiwan. In order to expand the indications of international new drugs and help domestic pharmaceutical companies successfully conduct high-quality clinical trials and drug development, we established the Taiwan Clinical Trial Consortium for Genitourinary Cancers. The purpose of TCTCGU

1. Connect the resources of clinical trial centers in alliance hospitals to accelerate clinical trial timelines.
2. Assist pharmaceutical company to conduct clinical trial.
3. Conduct PI-initiated clinical trial.
4. Participate in international multi-center institution clinical trial.
5. Assist patients to find proper therapy strategy.
6. Identify novel biomarkers and prognostic indicators in urinary tract cancers.

Clinical trial

International cooperation

Currently, we are continuing to implement a total of 40 international multi-center clinical trials, involving a total of 342 patients. The number of cooperation trials and patients continues to increase. The important results are excerpted as follows:

• 1. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer

  

• Darolutamide and survival in metastatic, hormone-sensitive prostate cancer.

  

• Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer

  

• Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma

  

• Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial

  

• Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study

  

• Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma

  

  All drugs have been approved by FDA/TFDA.

Economic benefits

The success of clinical trials accelerates the progress of drugs on the market, allowing more people in Taiwan to obtain better and more suitable treatments.

1. Darolutamide, Phase III
2. Olaparib, Phase III
3. Pembrolizumab, Phase III
4. Atezolizumab, Phase III
5. Erdafitinib, Phase III
6. Enfortumab Vedotin, Phase III

Society aspect:

1. Combined biotechnology research of our consortium and other company research center
2. Give suggestion of our clinical application view to company
3. Offer clinical trial service before marketing
4. Assist to evaluate new drug and medical device safety, efficacy
5. To promote potential new drug and medical device marketing to benefit people