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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
Must not have
Major surgery within 4 weeks of starting study treatment
Radiotherapy to target lesions (measurable disease) ≤ 12 weeks prior to enrolment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
Select...
My condition worsened despite treatment with specific prostate cancer medications.
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had major surgery in the last 4 weeks.
Select...
I have had radiation on my cancer spots less than 12 weeks ago.
Select...
I have brain metastases.
Select...
My cancer has large soft tissue lesions not seen on a specific PET scan.
Select...
I have a serious heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Proportions of patients with decreased PSA from baseline and the magnitude of change

Side effects data

From 2023 Phase 3 trial • 831 Patients • NCT03511664
43%
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%
Asthenia
6%
Pyrexia
6%
Hypertension
5%
Pain
5%
Abdominal pain
5%
Blood creatinine increased
5%
Hypophosphataemia
5%
Insomnia
2%
Sepsis
2%
Acute kidney injury
1%
Pancytopenia
1%
Infection
1%
Urosepsis
1%
Dehydration
1%
Ischaemic stroke
1%
Spinal cord compression
1%
Syncope
1%
Mental status changes
1%
Urinary retention
1%
Urinary tract obstruction
1%
Pulmonary embolism
1%
Deep vein thrombosis
1%
Hypotension
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
132 Previous Clinical Trials
69,667 Total Patients Enrolled
9 Trials studying Prostate Cancer
6,703 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
2 Trials studying Prostate Cancer
871 Patients Enrolled for Prostate Cancer

Media Library

177Lu-PSMA-617 (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT04663997 — Phase 2
Prostate Cancer Research Study Groups: Docetaxel, 177 Lu-PSMA-617
Prostate Cancer Clinical Trial 2023: 177Lu-PSMA-617 Highlights & Side Effects. Trial Name: NCT04663997 — Phase 2
177Lu-PSMA-617 (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04663997 — Phase 2
~5 spots leftby Dec 2024
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