Your session is about to expire
← Back to Search
Radiopharmaceutical
177Lu-HTK03170 for Prostate Cancer
Phase 1 & 2
Recruiting
Research Sponsored by British Columbia Cancer Agency
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first documented psa response till 4 weeks follow up, assessed up to 24 months post end of last cycle
Awards & highlights
Study Summary
This trial will test a new cancer treatment on people with mCRPC. The study will measure how well the treatment works and how safe it is.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread, despite previous treatments like abiraterone or enzalutamide. They must have good blood counts, kidney and liver function, be able to follow the trial procedures, and use contraception if necessary. Excluded are those who've had recent cancer therapies or surgeries, active heart disease, other cancers, brain metastases or certain conditions affecting saliva production.Check my eligibility
What is being tested?
The study tests a new radioactive drug called 177Lu-HTK03170 in men with PSMA-positive mCRPC. The treatment amount will increase each cycle based on personalized calculations from imaging results. Researchers will monitor tumor response through scans and blood tests for two years or until the disease progresses.See study design
What are the potential side effects?
Possible side effects include radiation-related risks such as nausea and fatigue; damage to organs near tumors; changes in blood cell counts leading to increased infection risk; potential kidney impairment; and dry mouth if salivary glands absorb some of the drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of first documented psa response till 4 weeks follow up, assessed up to 24 months post end of last cycle
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first documented psa response till 4 weeks follow up, assessed up to 24 months post end of last cycle
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the number of subjects with markedly abnormal laboratory tests (including ECG) at least once post-injection
To determine the MTIA or a recommended safe initial IA of 177Lu-HTK03170 to measure dosimetry and initiate treatment
To determine the antitumour effect of 177Lu-HTK03170 therapy measured by radiographic ORR per RECIST v1.1 in subjects who have PSMA-positive mCRPC
+3 moreSecondary outcome measures
Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score
Duration of PSA responses
Duration of radiographic response
+5 moreOther outcome measures
To assess the dose-response relationship between radiation delivered to tumour lesions and radiographic objective response
To assess whether circulating tumour DNA/RNA can be used to predict treatment response
Trial Design
1Treatment groups
Experimental Treatment
Group I: 177Lu HTK03170 Phase I/IIExperimental Treatment2 Interventions
Phase I, the administered activity will be 1.1 GBq ± 10% as an intravenous infusion over a time of 10 to 30 minutes. Initial Activity (IA) escalation will only occur on the initial dosimetry IA, with an increase of 30% over the initial IA (used for dosimetry) at each subsequent level ( 1.65 GBq, 2.5 GBq, 3.7 GBq) in up to 12 participants. Personalized dosimetry will be calculated for each subject.
Phase II, subjects will be treated with an initial IA of 177Lu-HTK03170 at the MTIA as determined during Phase I or 13.7 GBq whichever is lower. Treatment is administered as an intravenous infusion over a time of 10 - 30 minutes. Personalized dosimetry will be calculated for each subject so that subsequent treatments will be estimated to remain within the absorbed cumulative dose limits of 28Gy and 35Gy for kidneys and salivary glands, adjusted iteratively over the 4 remaining treatment cycles separated by 8 weeks. Up to 32 subjects will be enrolled to continue efficacy evaluation.
Find a Location
Who is running the clinical trial?
British Columbia Cancer AgencyLead Sponsor
171 Previous Clinical Trials
90,461 Total Patients Enrolled
24 Trials studying Prostate Cancer
5,812 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 4 weeks.I have not had radiation on my cancer spots in the last 4 weeks.I am a man aged 18 or older.I have a history of factors causing dry mouth or currently have mild to severe dry mouth.I do not have any other active invasive cancer.I have brain metastases.I have previously received PSMA-targeted radiation therapy.I have active cancer in the spine.I can take care of myself but might not be able to do heavy physical work.My kidney, liver, and bone marrow are functioning well.I have a serious heart condition.I have been diagnosed with prostate cancer.I haven't had any cancer treatments in the last 28 days.I have severe blockage in my urinary tract.My cancer progressed despite treatment with specific prostate cancer medications.I have recovered from side effects of previous cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: 177Lu HTK03170 Phase I/II
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary objective of this research endeavor?
"The aim of this medical trial, which analyses radiation dosimetry over an 8-14 week period post treatment cycle, is to measure the efficacy of 177Lu-HTK03170 in patients with PSMA-positive mCRPC previously exposed to ARAT. Secondary objectives include monitoring Progression Free Survival (PFS) - calculated as time until PSA progression, radiographic progression or clinical decline per PCWG3 criteria; Time To First Symptomatic Skeletal Event (SSE), and 6 months Progression Free Survival rate measured by PSA levels, objective disease markers or symptoms."
Answered by AI
Is this experiment currently recruiting participants?
"Clinicaltrials.gov indicates that enrollment for this clinical trial has ended; the study was first posted on March 1st, 2023 and subsequently updated November 28th 2022. Even though recruitment is closed at present, 1267 other trials are currently open to new participants."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger