Your session is about to expire
← Back to Search
Radioisotope Therapy
177Lu-PSMA-617 vs. ARDT for Prostate Cancer (PSMAfore Trial)
Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have progressive mCRPC.
Participants must have progressed only once on prior second generation ARDT (abiraterone, enzalutamide, darolutamide, or apalutamide).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until date of death from any cause, assessed up to 43 months (estimated final os analysis)
Awards & highlights
PSMAfore Trial Summary
This trial is comparing two different treatments for men with metastatic castration resistant prostate cancer who have previously been treated with an alternate androgen receptor downregulation therapy. The study will compare how well each treatment improves the participant's rPFS (progression free survival) or death.
Who is the study for?
Adults over 18 with advanced prostate cancer that's resistant to castration and has spread, who've only had one type of hormone therapy (like abiraterone or enzalutamide) but not chemo for this stage. They must have a low testosterone level, be in good physical shape (ECOG 0-1), and show positive signs on a specific PET scan. Major organs need to function well, they can't have severe allergies to trial drugs or certain heart conditions, and should agree to use contraception.Check my eligibility
What is being tested?
The study is testing if the drug 177Lu-PSMA-617 improves survival without cancer progression compared to changing the current hormone therapy in men whose prostate cancer has worsened despite treatment. About 450 participants will be randomly assigned equally into two groups: one receiving the new drug and supportive care; the other getting an alternative hormone therapy plus supportive care.See study design
What are the potential side effects?
Possible side effects include reactions related to radiation exposure from radioligand therapy like nausea, dry mouth/salivary gland swelling, kidney damage, blood cell count changes leading to increased infection risk or bleeding problems. Hormone therapies may cause fatigue, hot flashes, weakened bones/muscles.
PSMAfore Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is worsening despite treatment.
Select...
My cancer has worsened only once after treatment with a specific prostate cancer medication.
Select...
My testosterone levels are very low.
Select...
I am 18 years old or older.
Select...
My prostate cancer has been confirmed by a lab test.
Select...
I have at least one cancer spread that shows on scans taken before joining the study.
Select...
I have recovered from major side effects of my previous cancer treatments, except for hair loss.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
PSMAfore Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until date of death from any cause, assessed up to 43 months (estimated final os analysis)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until date of death from any cause, assessed up to 43 months (estimated final os analysis)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic Progression Free Survival (rPFS)
Secondary outcome measures
Biochemical response
Pain
European Quality of Life (EuroQol) - 5 Domain 5 Level scale (EQ-5D- 5L)
+9 moreSide effects data
From 2023 Phase 3 trial • 831 Patients • NCT0351166443%
Fatigue
39%
Dry mouth
35%
Nausea
30%
Anaemia
23%
Back pain
22%
Arthralgia
21%
Decreased appetite
19%
Constipation
19%
Diarrhoea
18%
Vomiting
17%
Thrombocytopenia
14%
Lymphopenia
12%
Leukopenia
11%
Weight decreased
10%
Urinary tract infection
10%
Bone pain
9%
Oedema peripheral
9%
Dyspnoea
9%
Neutropenia
9%
Pain in extremity
8%
Cough
8%
Dizziness
7%
Hypocalcaemia
7%
Haematuria
7%
Fall
7%
Hypokalaemia
7%
Headache
6%
Hypertension
6%
Pyrexia
6%
Asthenia
5%
Pain
5%
Abdominal pain
5%
Blood creatinine increased
5%
Hypophosphataemia
5%
Insomnia
2%
Sepsis
2%
Acute kidney injury
1%
Mental status changes
1%
Urinary tract obstruction
1%
Urinary retention
1%
Infection
1%
Urosepsis
1%
Deep vein thrombosis
1%
Dehydration
1%
Pancytopenia
1%
Hypotension
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Spinal cord compression
1%
Syncope
1%
Subdural haematoma
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
Best Supportive/Best Standard of Care (BS/BSOC) Alone
PSMAfore Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 177Lu-PSMA-617Experimental Treatment3 Interventions
Participants will receive 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT may be used.
Group II: Androgen receptor-directed therapy (ARDT)Active Control3 Interventions
For participants randomized to the ARDT arm, the change of ARDT treatment will be administered per the physician's orders. Best supportive care, including ADT may be used.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
177Lu-PSMA-617
2018
Completed Phase 3
~840
68Ga-PSMA-11
2019
Completed Phase 3
~170
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,196,885 Total Patients Enrolled
33 Trials studying Prostate Cancer
5,838 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had chemotherapy, immunotherapy, or biological therapy for prostate cancer.My prostate cancer is worsening despite treatment.I am fully active or can carry out light work.My cancer has worsened only once after treatment with a specific prostate cancer medication.My organs are functioning well, including my bone marrow, liver, kidneys, and I have a good level of albumin.I am eligible for treatments other than ARDT due to certain mutations or biomarkers in my condition.I have brain metastases but am not stable, have symptoms, or need steroids for brain function.My prostate cancer is worsening, shown by rising PSA levels or new cancer spots.My prostate cancer has been confirmed by a lab test.I have had PSMA-targeted therapy before.I am not currently on any strong cancer treatments like chemotherapy.I have severe issues controlling my bladder or urine flow.I currently have a confirmed case of COVID-19.My testosterone levels are very low.I am experiencing symptoms or have been diagnosed with potential spinal cord compression.I haven't had specific treatments in the last 6 months.I have not received blood transfusions or bone marrow stimulants just to qualify for this study.I am a sexually active male and agree to use a condom during the study and for 14 weeks after.I am 18 years old or older.My doctor thinks I need a different depression treatment.I cannot raise my arms.My prostate cancer has been confirmed by a lab test.I do not have any mental or physical health conditions that could affect the study's results.I have at least one cancer spread that shows on scans taken before joining the study.I have recovered from major side effects of my previous cancer treatments, except for hair loss.I have other cancers that could affect my life span or interfere with this cancer's assessment.I am fully active or restricted in physically strenuous activity but can do light work.My cancer progressed after one treatment with specific hormone therapies.I am 18 years old or older.I have taken bicalutamide or similar drugs, but not as part of advanced hormone therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Androgen receptor-directed therapy (ARDT)
- Group 2: 177Lu-PSMA-617
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Prostate Cancer Patient Testimony for trial: Trial Name: NCT04689828 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a risk of negative side-effects from 177Lu-PSMA-617?
"There is some evidence from prior clinical trials to support the efficacy of 177Lu-PSMA-617, and it has received multiple rounds of safety testing. We rate its safety as a 3."
Answered by AI
Are new participants being accepted into this study at present?
"The clinical trial detailed on clinicaltrials.gov is not presently looking for candidates, as the last update was on November 7th, 2022. The study was originally posted on June 15th, 2021. There are 1289 other trials that are currently enrolling participants."
Answered by AI
Who else is applying?
What site did they apply to?
Novartis Investigative Site
Tulane University Health Sciences Center .
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
What state do they live in?
Tennessee
Why did patients apply to this trial?
Right now I'm on going therapy with apalutamida and leuprorreline (1 injection each 6 months).
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Novartis Investigative Site: < 48 hours
Average response time
- < 2 Days
Popular Categories
Share this study with friends
Copy Link
Messenger