18 and older, any sex, with Castration-Resistant Prostate Carcinoma or Metastatic Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phases I and II)Primary· Up to 3 years
Safety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data. Adverse events will then be quantified via CTCAE 4.0.
Group
Value
95% CI
Arm I (Sirolimus, Docetaxel, Carboplatin)
2
Arm II (Sirolimus, Docetaxel, Carboplatin)
2
Phase 1 Group
0
Percentage of Patients With Reduction in Prostate Specific Antigen According to the Prostate Cancer Working Group 2 (PCWG2) Criteria (Phases I and II)Secondary· Baseline to up to 3 years
PSA decline from the level at registration will be quantified for each patient and proportion of patients with PSA decline divided by the total number of patients enrolled in study will be described.
Group
Value
95% CI
Arm I (Sirolimus, Docetaxel, Carboplatin)
36
Arm II (Sirolimus, Docetaxel, Carboplatin)
36
Phase 1 Group
50
Adverse events — posted to ClinicalTrials.gov
Time frame: During time on study to 30 days after last therapy. This was up to 2 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This partially randomized phase I/II trial studies the side effects and how well sirolimus works when given together with docetaxel and carboplatin in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). Biological therapies, such as sirolimus, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sirolimus together with docetaxel and carboplatin may kill more tumor cells.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04832438 — 9-ING-41 Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma
· Phase 2
· withdrawn
NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer
· Phase 2
· not yet recruiting
NCT07346196 — A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck
· Phase 2
· not yet recruiting
NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive
· Phase 3
· not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa
· Phase 2
· recruiting
Other recruiting trials for Castration-Resistant Prostate Carcinoma
Currently open trials in the same condition.
NCT06942104 — Imaging of Solid Tumors Using 18F-TRX
· Phase 1
· recruiting
NCT06632977 — Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
· Phase 2
· recruiting
NCT06305598 — Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration
· Phase 1
· recruiting
NCT06236139 — Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate
· Phase 1, PHASE2
· recruiting
NCT06145633 — Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
· Phase 2
· recruiting
Other University of Washington trials
Trials by the same sponsor.
NCT07430852 — Inherited and Environmental Risks Acting on Body Weight
· NA
· not yet recruiting
NCT07466498 — Estrogen to Improve Quality of Life for Men With Newly Diagnosed or Recurrent Metastatic Hormone Sensitive Prostate Canc
· Phase 2
· not yet recruiting
NCT06422299 — Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Youn
· NA
· not yet recruiting
NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer
· Phase 2
· not yet recruiting
NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Washington
Last refreshed: 1 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02565901.