NCT04298983: RAD 1805

Abemaciclib in Combination With Androgen Deprivation Therapy for Locally Advanced Prostate Cancer

Terminated Phase 2 Results posted Last updated 19 March 2025

What this trial tests

Phase 2 trial testing Abemaciclib 150 MG by mouth twice daily in Prostate Cancer in 9 participants. Terminated before completion.

Timeline

25 February 2021

Primary endpoint
18 July 2024

4 September 2024

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	25 February 2021
Primary completion	18 July 2024
Estimated completion	4 September 2024
Sites	1 location across United States

Drugs / interventions tested

• Abemaciclib 150 MG by mouth twice daily — full drug profile →
• Androgen deprivation therapy (ADT) — full drug profile →
• Radiation Therapy — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

University of Alabama at Birmingham

Who can join

18 and older, male only, with Prostate Cancer. 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.

Clinical Response Rates Primary · Baseline to 24 months

Clinical response rates will be assessed by percentage of patients who achieve the PSA nadir levels of \< 0.5ng/ml on treatment

Group	Value	95% CI
Abemaciclib + ADT+ RT	2

Number of Patients With PSA Declines Prior to Radiotherapy Secondary · Up to 3 months of treatment

Number of patients with PSA declines prior to radiotherapy- calculated from nadir level prior to initiation of radiation therapy

Group	Value	95% CI
Abemaciclib + ADT+ RT	2

Number of Patients to Experience PSA Failure Secondary · Baseline up to 24 months

Number of patients to experience PSA failure will be analyzed using the Kaplan-Meier method

Group	Value	95% CI
Abemaciclib + ADT+ RT	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Each participant was assessed up to 24 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Abemaciclib + ADT+ RT

Serious: 4/9 (44%)

Deaths: 0/9

Serious adverse events (1 terms)

Reaction	System	Abemaciclib + ADT+ RT
Lipase Increased	Investigations	—

Most-reported serious reactions: Lipase Increased.

Data from ClinicalTrials.gov NCT04298983 adverse events section.

Sponsor's own description

This Phase II study is designed to study the clinical and radiologic response, as well as, safety and tolerability of abemaciclib in combination with androgen deprivation therapy (ADT) in patients with localized high-risk or locally advanced prostate cancer who are eligible for definitive radiation therapy (RT) and androgen deprivation therapy (ADT).

Publications & conference data

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

1. Targeting signaling pathways in prostate cancer: mechanisms and clinical trials.
   He Y, Xu W, Xiao YT, Huang H, et al · · 2022 · cited 192× · PMID 35750683 · DOI 10.1038/s41392-022-01042-7
2. Radiotherapy as a tool to elicit clinically actionable signalling pathways in cancer.
   Petroni G, Cantley LC, Santambrogio L, Formenti SC, et al · · 2022 · cited 154× · PMID 34819622 · DOI 10.1038/s41571-021-00579-w
3. CDK4, CDK6/cyclin-D1 Complex Inhibition and Radiotherapy for Cancer Control: A Role for Autophagy.
   Nardone V, Barbarino M, Angrisani A, Correale P, et al · · 2021 · cited 29× · PMID 34445095 · DOI 10.3390/ijms22168391
4. Advances in molecular targeted therapies to increase efficacy of (chemo)radiation therapy.
   Viktorsson K, Rieckmann T, Fleischmann M, Diefenhardt M, et al · · 2023 · cited 19× · PMID 37041372 · DOI 10.1007/s00066-023-02064-y
5. Review of Current Treatment Intensification Strategies for Prostate Cancer Patients.
   Wasim S, Park J, Nam S, Kim J. · · 2023 · cited 14× · PMID 38067321 · DOI 10.3390/cancers15235615
6. Cyclin-Dependent Kinase Inhibition in Prostate Cancer: Past, Present, and Future.
   Siskin M, Economides MP, Wise DR. · · 2025 · cited 7× · PMID 40075623 · DOI 10.3390/cancers17050774
7. Quo Vadis Advanced Prostate Cancer Therapy? Novel Treatment Perspectives and Possible Future Directions.
   Kvízová J, Pavlíčková V, Kmoníčková E, Ruml T, et al · · 2021 · cited 4× · PMID 33921501 · DOI 10.3390/molecules26082228
8. Evolving Treatments and Resistance Mechanisms in Prostate Cancer Therapeutics.
   Sai Rishma Reddy GSV, Kumar A, Sharma NK, Samanta K, et al · · 2026 · PMID 41988377 · DOI 10.1021/acsptsci.5c00757