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Radioisotope Therapy
177Lu-PSMA-617 + Standard Therapy for Prostate Cancer (PSMAddition 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
Patients must be adults ≥18 years of age
Patients must have an ECOG performance status of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until date of death from any cause, assessed up to 50 months (estimated final os analysis)
Awards & highlights
PSMAddition Trial Summary
This trial is testing a new cancer treatment in men with mHSPC. The new treatment is given with the standard of care, which is a combination of two existing treatments. 1126 patients will be randomly assigned to either the new treatment or the standard of care.
Who is the study for?
Adult men with metastatic hormone-sensitive prostate cancer, who have visible bone or soft tissue/visceral lesions and are either treatment-naive or minimally treated. They must be over 18 years old, have a life expectancy of more than 9 months, good organ function, no severe concurrent conditions, and not be on other clinical trials.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of adding a drug called 177Lu-PSMA-617 to the standard prostate cancer treatments (Androgen Receptor Directed Therapy + Androgen Deprivation Therapy) compared to the standard treatments alone in about 1126 patients.See study design
What are the potential side effects?
Potential side effects include reactions related to radiation exposure from radioligand therapy like nausea, fatigue, blood cell count changes that can affect immunity and clotting. Organ-specific toxicity such as kidney damage may also occur.
PSMAddition Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have prostate cancer that has spread, confirmed by a biopsy.
Select...
I have metastatic prostate cancer and am expected to live more than 9 months.
PSMAddition Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until date of death from any cause, assessed up to 50 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 50 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
Brief Pain Inventory-short Form (PBI-SF)
Change in nadir level of PSA lower than 0.2 ng/ml
Disease Control Rate (DCR)
+13 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
PSMAddition Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 177Lu-PSMA-617Experimental Treatment4 Interventions
Participant will receive 7.4 GBq (+/- 10%) 177Lu-PSMA-617, once every 6 weeks (+/- 1 week) for a planned 6 cycles, in addition to the Standard of Care (SOC); ARDT +ADT is considered as SOC and treatment will be administered per the physician's order
Group II: Standard of CareActive Control3 Interventions
For participants randomized to Standard of Care arm, ARDT +ADT is considered as SOC and treatment will be administered per the physician's order
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
ADT
2009
Completed Phase 3
~5120
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,196,206 Total Patients Enrolled
33 Trials studying Prostate Cancer
5,838 Patients Enrolled for Prostate Cancer
Alliance Foundation Trials, LLC.OTHER
23 Previous Clinical Trials
23,888 Total Patients Enrolled
3 Trials studying Prostate Cancer
11,950 Patients Enrolled for Prostate Cancer
RTOG Foundation, Inc.OTHER
6 Previous Clinical Trials
368 Total Patients Enrolled
1 Trials studying Prostate Cancer
188 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had specific radiation treatments or PSMA-targeted therapy in the last 6 months.I agree to use a condom during the study and for 14 weeks after, and not to donate sperm.I am not currently on any strong cancer treatments like chemotherapy.You have taken any experimental drugs within the last 30 days before the start of the study.I do not have any mental or physical health conditions that could affect the study's results.I cannot raise my arms.My liver function tests are within the required limits.I have been cancer-free for over 3 years, except for non-melanoma skin cancer or superficial bladder cancer.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.I have prostate cancer that has spread, confirmed by a biopsy.I have prostate cancer and have had minimal or no prior treatment.I have cancer that has spread to my bones, lymph nodes, or other organs.I have metastatic prostate cancer and am expected to live more than 9 months.My cancer is growing quickly and needs immediate treatment with taxane-based chemotherapy.I have not received a transfusion just to qualify for this study.My bladder issues are under control with current treatments.I have serious heart issues or a family history of severe heart problems.My cancer has spread to my bones, lymph nodes outside the pelvis, or other organs.I am experiencing symptoms or have been diagnosed with potential spinal cord compression.I have not had any prostate cancer treatment except for those listed in criteria 11.My brain metastases are stable, and I'm not on steroids for them.
Research Study Groups:
This trial has the following groups:- Group 1: 177Lu-PSMA-617
- Group 2: Standard of Care
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: NCT04720157 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current openings for enrollees in this experiment?
"That is accurate, the ongoing clinical trial is recruiting 1126 participants from 52 sites, as stated on clinicaltrials.gov. The first posting was on June 9th, 2021 and the most recent edit was on October 26th, 2022."
Answered by AI
Do most of the trial locations for this research project fall within North America?
"Currently, there are 52 locations across the country enrolling patients for this study. If you're interested in participating, it may be helpful to select a location near you to minimize travel-related logistics."
Answered by AI
Is there a high risk of danger for people using 177Lu-PSMA-617?
"According to our team's assessment, 177Lu-PSMA-617 rates a 3 on the safety scale. This is due to it being in Phase 3 trials, which means that there is both efficacy data as well as multiple rounds of safety data supporting its use."
Answered by AI
What is the maximum number of participants in this experiment?
"The sponsor, Novartis Pharmaceuticals, needs to recruit 1126 patients that match the study's inclusion criteria from different sites including University of Pittsburgh Cancer Institute SC-3 in Pittsburgh, Pennsylvania and UT Health San Antonio Mays Cancer Center in San Antonio, Texas."
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
Quebec
Texas
How old are they?
65+
What site did they apply to?
Texas Oncology Texas Oncology - Plano West
UT Health San Antonio Mays Cancer Center
University of Miami
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am waiting for surgery. I was recently diagnosed with prostate cancer. I have started hormone therapy about 30 day ago. I am currently taking Casodex 50mg. I am currently being treated by Dr Pruthi, a urologist at UT Health and I have my first appointment with Dr Ramamurthy, a Medical Oncologist at the Mays Cancer Center on March 20th. I was curious about clinical trials and what they might offer.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Novartis Investigative Site: < 48 hours
Average response time
- < 2 Days
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