OBJECTIVES: Understand what fatigue and pain-specific PRO instruments are being used in the most recent clinical trials for recently approved prostate cancer drugs. METHODS: We searched the ClinicalTrials.gov database. Searches were limited to drugs recently approved by the FDA and EMA (cabazitaxel, docetaxel, degarelix, histrelin, bicalutamide, leuprolide, leuprorelin, triptorelin), but not to any specific prostate cancer stage. The search terms used were “quality of life OR QOL OR patient reported outcome” (outcome measure) and “prostate cancer” (for condition). Phase I trials were not considered. We supplemented the search with reviews of EMA or CMDh drug labels for PRO information. The search was validated with a Medline search using the above limitations and search terms, limited to articles published since 1 January 1999. RESULTS: 67 clinical trials with PROs or QoL were identified, 33 docetaxel, 14 bicalutamide, 13 leuprolide/leuprorelin, 5 degarelix, 2 triptorelin and 1 cabazitaxel. The MOTIF trial, to determine the efficacy of modafinil in alleviating fatigue in PC patients undergoing docetaxel-based chemotherapy, was the only trial to assess fatigue. FACIT-F and SOMA were the PRO instruments used. Two docetaxel trials and the cabazitaxel trials were the only ones to have used a pain-specific PRO, the PPI item from the McGill Pain Questionnaire, to measure this symptom. CONCLUSIONS: Despite the ubiquity of fatigue as a side effect of both hormonal therapy and chemotherapy for prostate cancer, only one trial assessed this symptom with a dedicated PRO instrument. Although pain can be one of the most debilitating symptoms associated with prostate cancer, only three trials used a dedicated PRO instrument to assess this symptom. It is unclear why more PC trials do not use fatigue and pain-specific PRO instruments.