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Kinase Inhibitor

Abemaciclib + Radioligand Therapy for Prostate Cancer (UPLIFT Trial)

Phase 1 & 2
Waitlist Available
Led By Vadim S Koshkin, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years.
Patients must have adenocarcinoma histology.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

UPLIFT Trial Summary

This trial is testing the safety and effectiveness of abemaciclib before radioligand therapy in treating patients with castration resistant prostate cancer.

Who is the study for?
Men aged 18+ with metastatic castration resistant prostate cancer that has progressed despite previous taxane-based chemotherapy can join. They must have adequate organ function, no small cell/neuroendocrine carcinoma, and not be on recent anti-cancer therapy or have serious concurrent conditions. HIV-positive individuals on effective treatment are eligible.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of abemaciclib followed by radioligand therapy with 177Lu-PSMA-617 in men with advanced prostate cancer. Abemaciclib is a kinase inhibitor aiming to stop cancer growth, while 177Lu-PSMA-617 targets and kills tumor cells.See study design
What are the potential side effects?
Potential side effects include fatigue, nausea, diarrhea, low blood counts leading to increased infection risk or bleeding problems, liver issues, kidney impairment and possibly others depending on individual health conditions.

UPLIFT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is of the adenocarcinoma type.
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My PET scan shows at least 3 areas with higher PSMA levels than my liver.
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My organs and bone marrow are functioning well.
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I can swallow pills.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I am HIV positive, on treatment, and my viral load is undetectable.
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My kidney function is within the safe range for the trial.
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I have another cancer, but it won't affect this trial's treatment.
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My hemoglobin level is above 8.0, possibly after a transfusion.
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I have been treated with a new hormone therapy like abiraterone.
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I have undergone treatment to lower my testosterone due to cancer.
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My prostate cancer has spread and is not responding to hormone therapy.
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I've had taxane-based chemotherapy and recovered from its effects, except for possible hair loss or mild nerve damage.
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My prostate cancer diagnosis was confirmed through a biopsy.
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I am able to get out of my bed or chair and move around.
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My hepatitis B virus load is undetectable with treatment.

UPLIFT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in maximum standardized uptake value (SUVmax) across three lesions on gallium Ga 68 gozetotide (68Ga-PSMA-11) positron emission tomography (PET) scan (Part B)
Proportion of participants with DLTs (Part A)
Recommended phase 2 dose (Part A)
Secondary outcome measures
Disease control rate (Part B)
Median duration of response (DOR) (Part B)
Median overall survival (OS) (Part B)
+4 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490
91%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
Neutropenia
18%
White blood cell count decreased
15%
Alopecia
14%
Weight decreased
14%
Dry mouth
14%
Platelet count decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Dyspepsia
11%
Oedema peripheral
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Alanine aminotransferase increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Flatulence
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Myalgia
5%
Rash
2%
Cellulitis
2%
Pleural effusion
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pneumonitis
1%
Pneumothorax
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib

UPLIFT Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Recommended Phase 2 dose of Abemaciclib, 177Lu-PSMA-617Experimental Treatment2 Interventions
Patients receive the recommended phase 2 dose of abemaciclib lead-in on days 1-14 and lutetium Lu 177 vipivotide tetraxetan IV over 30 minutes on day 15. Treatment repeats every 6 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Part A: Abemaciclib, 177Lu-PSMA-617Experimental Treatment2 Interventions
Patients receive abemaciclib lead-in on days 1-14 and lutetium Lu 177 vipivotide tetraxetan IV over 30 minutes on day 15. Treatment repeats every 6 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1480

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,491 Previous Clinical Trials
11,930,577 Total Patients Enrolled
52 Trials studying Prostate Cancer
17,033 Patients Enrolled for Prostate Cancer
Eli Lilly and CompanyIndustry Sponsor
2,603 Previous Clinical Trials
3,199,627 Total Patients Enrolled
15 Trials studying Prostate Cancer
2,016 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,777 Total Patients Enrolled
28 Trials studying Prostate Cancer
1,930 Patients Enrolled for Prostate Cancer

Media Library

Abemaciclib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05113537 — Phase 1 & 2
Prostate Cancer Research Study Groups: Part B: Recommended Phase 2 dose of Abemaciclib, 177Lu-PSMA-617, Part A: Abemaciclib, 177Lu-PSMA-617
Prostate Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT05113537 — Phase 1 & 2
Abemaciclib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05113537 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaging in this medical research?

"Affirmative. Clinicaltrials.gov indicates that recruitment for this experiment is still in progress, with the original posting being on July 8th 2022 and an update occurring on September 8th of the same year. Presently, 30 individuals are sought from one medical site to participate."

Answered by AI

Is enrolment for this research endeavor active?

"That is correct. Per information on clinicaltrials.gov, this research project has been actively recruiting since July 8th 2022 and was last updated September 8th of the same year; with a goal to enlist 30 participants from one location."

Answered by AI

What is the primary aim of this research endeavor?

"The primary endpoint of this 6-week trial is to identify the Recommended phase 2 dose (Part A). Secondary endpoints include Disease control rate (Part B) - which quantifies a patient's best response or stable disease until progression - Radiographic progression free survival (Part B), and PSA50 response rate (Part B) - measuring how many patients achieved more than 50% decline in prostate specific antigen levels."

Answered by AI

What health conditions does Abemaciclib typically address?

"Abemaciclib is commonly employed to combat the risk of recurrence, but there are a variety of other applications such as advanced HR+ HER2- breast cancer, neoplasms and neuroendocrine tumours (NETs)."

Answered by AI
~2 spots leftby Dec 2025