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Radiopharmaceutical
Radiotherapy vs Chemotherapy for Prostate Cancer
Phase 2
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Progression on treatment with abiraterone and/or enzalutamide, or similar next-generation androgen receptor (AR) targeted therapy
Histological evidence of prostate cancer with no evidence of small cell component
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing a new therapy that uses high doses of radiation to target prostate cancer. They want to see if it's more effective than chemotherapy.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread, showing progression despite treatment with drugs like abiraterone or enzalutamide. They must have PSMA-positive cancer confirmed by PET imaging, be in fairly good health (ECOG 0-2), and have recovered from previous treatments. Excluded are those who've had certain prior therapies including 177Lu-PSMA, recent major surgery, uncontrolled medical conditions, brain metastases, or severe allergies to study drugs.Check my eligibility
What is being tested?
This trial is testing whether a new targeted radiation therapy called 177Lu PSMA-617 can slow the growth of prostate cancer more effectively than the standard chemotherapy drug Docetaxel. Patients will receive either the experimental therapy or standard chemotherapy to compare effectiveness.See study design
What are the potential side effects?
Possible side effects for both treatments include fatigue, nausea, hair loss (with Docetaxel), blood count changes increasing infection risk; kidney and liver function may also be affected. The new treatment might cause radiation-specific effects due to its targeting of cancer cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition worsened despite treatment with specific prostate cancer medications.
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My prostate cancer diagnosis was confirmed by a tissue sample and does not include small cell cancer.
Select...
My scans show PSMA positive metastatic disease using specific tracers.
Select...
I have had surgery to remove my testicles or I am on hormone therapy with low testosterone levels.
Select...
I am a man aged 18 or older.
Select...
I am able to care for myself and perform daily activities.
Select...
My prostate cancer is spreading despite hormone therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Adverse event (AE) profile (CTCAE v5.0)
Clinical benefit rate (CBR) > 24 weeks (RECIST v1.1).
Overall Survival
+7 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
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 177 Lu-PSMA-617Experimental Treatment1 Intervention
Group II: DocetaxelActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
177Lu-PSMA-617
2018
Completed Phase 3
~840
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,253 Total Patients Enrolled
10 Trials studying Prostate Cancer
6,935 Patients Enrolled for Prostate Cancer
Prostate Cancer CanadaOTHER
9 Previous Clinical Trials
7,326 Total Patients Enrolled
6 Trials studying Prostate Cancer
7,082 Patients Enrolled for Prostate Cancer
EndocyteIndustry Sponsor
35 Previous Clinical Trials
3,096 Total Patients Enrolled
3 Trials studying Prostate Cancer
1,072 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction to the study drug or its components in the past.I've had chemotherapy for hormone-resistant cancer or within a year for hormone-sensitive cancer.I have not had major surgery in the last 4 weeks.I have another cancer type, but it won't affect this cancer treatment's safety or results.I have not had PSMA-targeted therapy or radio-immunotherapy before, or it's been 6 months since my last radium-223 dose.My condition worsened despite treatment with specific prostate cancer medications.I have had radiation on my cancer spots less than 12 weeks ago.My prostate cancer diagnosis was confirmed by a tissue sample and does not include small cell cancer.My scans show PSMA positive metastatic disease using specific tracers.I do not have active spinal cord disease, but treated conditions are okay.I have recovered from side effects of previous cancer treatments.I have brain metastases.I have had surgery to remove my testicles or I am on hormone therapy with low testosterone levels.I am a man aged 18 or older.I am able to care for myself and perform daily activities.My cancer has large soft tissue lesions not seen on a specific PET scan.My prostate cancer is spreading despite hormone therapy.My organs are working well.I have a serious heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Docetaxel
- Group 2: 177 Lu-PSMA-617
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.
Is 177Lu-PSMA-617 a new experimental treatment?
"There are 337 different medical studies currently underway that involve 177Lu-PSMA-617. Most of these trials are in their third phase, with 132 total. The vast majority of these clinical trials are taking place in Fuzhou, Fujian; however, there are over 23000 other locations where similar research is being conducted."
Answered by AI
To what conditions or diseases is 177Lu-PSMA-617 commonly applied?
"177Lu-PSMA-617 can be used to fight against malignant neoplasms, sarcoma, and in some cases where patients have issued advance directives."
Answered by AI
When will 177Lu-PSMA-617 be cleared by the FDA?
"The lack of data regarding 177Lu-PSMA-617's efficacy results in it receiving a 2 for safety."
Answered by AI
At how many facilities is this trial currently underway?
"5 sites are presently running this trial, with locations in Vancouver, Montreal and Quebec City among others. If you enroll in the trial, it is best to choose a site closest to your location to minimize travel demands."
Answered by AI
How many subjects are being observed in this trial?
"That is correct. Currently, the online information hosted on clinicaltrials.gov says that this study is looking for more participants. The trial was created on December 17th 2020 and was last edited October 17th of this year. They are recruiting 200 individuals from 5 different locations."
Answered by AI
Are we looking for more test subjects for this experiment?
"That is accurate. The clinicaltrials.gov website indicates that this study, which was established on December 17th 2020, is currently looking for 200 participants at 5 different medical centres."
Answered by AI
Who else is applying?
What site did they apply to?
University Health Network
What portion of applicants met pre-screening criteria?
Met criteria
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