NCT02121639 (ProCAID) is a Phase 1, PHASE2 clinical trial of AZD5363 in Prostate Cancer, sponsored by University Hospital Southampton NHS Foundation Trust.

Who is sponsoring NCT02121639?

NCT02121639 is sponsored by University Hospital Southampton NHS Foundation Trust.

What drugs are being tested in NCT02121639?

Interventions in NCT02121639: Placebo, AZD5363.

What condition does NCT02121639 study?

NCT02121639 studies Prostate Cancer.

Is NCT02121639 still recruiting?

NCT02121639 is currently completed. Last updated 5 May 2022.

Last reviewed 2022-05-05 · How we verify

NCT02121639: ProCAID

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Open Label Phase I/Randomised,Double Blind Phase II Study in mCRPC of AZD5363 In Combination With DP Chemotherapy

Completed Phase 1, PHASE2 Last updated 5 May 2022

What this trial tests

Phase 1, PHASE2 trial testing Placebo in Prostate Cancer in 160 participants. Completed in 13 September 2021.

Timeline

29 January 2014

Primary endpoint
8 October 2020

13 September 2021

Quick facts

Lead sponsor	University Hospital Southampton NHS Foundation Trust
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	160
Start date	29 January 2014
Primary completion	8 October 2020
Estimated completion	13 September 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

Placebo
AZD5363 (azd5363) — full drug profile →

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

University Hospital Southampton NHS Foundation Trust

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the ProCAID study is to determine if the addition of the AKT inhibitor AZD5363 to docetaxel and prednisolone (DP) prolongs progression free survival (PFS) in Metastatic castration resistant prostate cancer to a degree worthy of further investigation

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The PI3K-AKT-mTOR Pathway and Prostate Cancer: At the Crossroads of AR, MAPK, and WNT Signaling.
Shorning BY, Dass MS, Smalley MJ, Pearson HB. · · 2020 · cited 437× · PMID 32630372 · DOI 10.3390/ijms21124507
Maximising the potential of AKT inhibitors as anti-cancer treatments.
Brown JS, Banerji U. · · 2017 · cited 184× · PMID 27919797 · DOI 10.1016/j.pharmthera.2016.12.001
Recent Advances in Prostate Cancer Treatment and Drug Discovery.
Nevedomskaya E, Baumgart SJ, Haendler B. · · 2018 · cited 176× · PMID 29734647 · DOI 10.3390/ijms19051359
Role of PI3K-AKT-mTOR Pathway as a Pro-Survival Signaling and Resistance-Mediating Mechanism to Therapy of Prostate Cancer.
Pungsrinont T, Kallenbach J, Baniahmad A. · · 2021 · cited 148× · PMID 34681745 · DOI 10.3390/ijms222011088
Pan-AKT Inhibitor Capivasertib With Docetaxel and Prednisolone in Metastatic Castration-Resistant Prostate Cancer: A Randomized, Placebo-Controlled Phase II Trial (ProCAID).
Crabb SJ, Griffiths G, Marwood E, Dunkley D, et al · · 2021 · cited 65× · PMID 33326257 · DOI 10.1200/jco.20.01576
AR and PI3K/AKT in Prostate Cancer: A Tale of Two Interconnected Pathways.
Tortorella E, Giantulli S, Sciarra A, Silvestri I. · · 2023 · cited 52× · PMID 36768370 · DOI 10.3390/ijms24032046
Role of Chemotherapy and Mechanisms of Resistance to Chemotherapy in Metastatic Castration-Resistant Prostate Cancer.
Lohiya V, Aragon-Ching JB, Sonpavde G. · · 2016 · cited 44× · PMID 27773999 · DOI 10.4137/cmo.s34535
ProCAID: a phase I clinical trial to combine the AKT inhibitor AZD5363 with docetaxel and prednisolone chemotherapy for metastatic castration resistant prostate cancer.
Crabb SJ, Birtle AJ, Martin K, Downs N, et al · · 2017 · cited 38× · PMID 28144789 · DOI 10.1007/s10637-017-0433-4

Verify or expand the search:

Other trials of AZD5363

Trials testing the same drug.

NCT03310541 — AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations · Phase 1 · completed
NCT02449655 — Trial of AZD5363 Plus Paclitaxel /AZD2014 Plus Paclitaxel in Biomarker Negative (PIK3CA/MEK/RAS/TP53/MET) Gastric Adenoc · Phase 2 · terminated
NCT02451956 — Study of AZD5363 in Combination With Paclitaxel, in Advanced Gastric Adenocarcinoma Patients Harboring PIK3CA Mutation a · Phase 2 · completed
NCT02423603 — PAKT: AZD5363 in Combination With Paclitaxel in Triple-Negative Advanced or Metastatic Breast Cancer · Phase 2 · completed
NCT02338622 — Trial of Olaparib in Combination With AZD5363 (ComPAKT) · Phase 1 · completed

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Other University Hospital Southampton NHS Foundation Trust trials

Trials by the same sponsor.

NCT07354971 — IMMUNO-FIT Observational Study · not yet recruiting
NCT07278622 — Virtual Group Prehabilitation Education (Surgery School) Feasibility Trial · NA · recruiting
NCT07357558 — A Qualitative Study Investigating the Lived Experiences and Impact of Reproductive Issues in Adults With Primary Ciliary · recruiting
NCT06851715 — Improving Quality of Life for Teenagers With Asthma · NA · recruiting
NCT07489677 — The Feasibility and Acceptability of a Collaborative Deprescribing Intervention to Reduce Anticholinergic Burden Among H · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02121639 (US National Library of Medicine, public domain)
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 Hospital Southampton NHS Foundation Trust
Last refreshed: 5 May 2022

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/NCT02121639.

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