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Abemaciclib + Radioligand Therapy for Prostate Cancer (UPLIFT Trial)
UPLIFT Trial Summary
This trial is testing the safety and effectiveness of abemaciclib before radioligand therapy in treating patients with castration resistant prostate cancer.
UPLIFT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowUPLIFT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 132 Patients • NCT02102490UPLIFT Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.My cancer is of the adenocarcinoma type.My PET scan shows at least 3 areas with higher PSMA levels than my liver.I do not have any active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.My organs and bone marrow are functioning well.You are not currently taking any experimental drugs for treatment.I have had radiation treatment to my lungs or liver.I am experiencing symptoms related to spinal cord pressure.I can swallow pills.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am HIV positive, on treatment, and my viral load is undetectable.My kidney function is within the safe range for the trial.My hemoglobin level is above 8.0, possibly after a transfusion.I have had severe side effects from previous radiation treatment.I have another cancer, but it won't affect this trial's treatment.I have been treated with a new hormone therapy like abiraterone.I haven't had any cancer treatments in the last 3 weeks.I had brain metastases but am symptom-free after treatment and not on steroids.I have recovered from previous cancer treatment side effects, except for hair loss or nerve issues.I have undergone treatment to lower my testosterone due to cancer.My prostate cancer has spread and is not responding to hormone therapy.I've had taxane-based chemotherapy and recovered from its effects, except for possible hair loss or mild nerve damage.I have no other major cancers that could affect my life expectancy or interfere with this study, except for certain skin cancers, non-muscle-invasive bladder cancer, or if I've been cancer-free for over 3 years.I haven't had certain radioactive treatments or half-body radiation in the last 6 months.My prostate cancer diagnosis was confirmed through a biopsy.I am able to get out of my bed or chair and move around.My cancer is either small cell or neuroendocrine type.My hepatitis B virus load is undetectable with treatment.I have been treated with CDK4/6 inhibitors before.I have had PSMA-targeted radioligand therapy before.I have a history of serious heart rhythm problems or sudden cardiac arrest.
- Group 1: Part B: Recommended Phase 2 dose of Abemaciclib, 177Lu-PSMA-617
- Group 2: Part A: Abemaciclib, 177Lu-PSMA-617
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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)."
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