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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).

Must not have

Prior treatment with cytotoxic chemotherapy for castration resistant or castrate sensitive prostate cancer, immunotherapy or biological therapy.

Previous PSMA-targeted radioligand therapy.

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

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is worsening despite treatment.

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My cancer has worsened only once after treatment with a specific prostate cancer medication.

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My testosterone levels are very low.

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I am 18 years old or older.

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My prostate cancer has been confirmed by a lab test.

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I have at least one cancer spread that shows on scans taken before joining the study.

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I have recovered from major side effects of my previous cancer treatments, except for hair loss.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had chemotherapy, immunotherapy, or biological therapy for prostate cancer.

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I have had PSMA-targeted therapy before.

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I am not currently on any strong cancer treatments like chemotherapy.

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I have severe issues controlling my bladder or urine flow.

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I currently have a confirmed case of COVID-19.

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I am experiencing symptoms or have been diagnosed with potential spinal cord compression.

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I haven't had specific treatments in the last 6 months.

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I have not received blood transfusions or bone marrow stimulants just to qualify for this study.

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I am a sexually active male and agree to use a condom during the study and for 14 weeks after.

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I cannot raise my arms.

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I have other cancers that could affect my life span or interfere with this cancer's assessment.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until date of death from any cause, assessed up to 43 months (estimated final os analysis) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Radiographic Progression Free Survival (rPFS)

Secondary study objectives

Biochemical response

Pain

European Quality of Life (EuroQol) - 5 Domain 5 Level scale (EQ-5D- 5L)

+9 more

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

Oedema peripheral

Dyspnoea

Neutropenia

Pain in extremity

Cough

Dizziness

Hypocalcaemia

Haematuria

Fall

Hypokalaemia

Headache

Asthenia

Pyrexia

Hypertension

Pain

Abdominal pain

Blood creatinine increased

Hypophosphataemia

Insomnia

Sepsis

Acute kidney injury

Pancytopenia

Infection

Urosepsis

Dehydration

Ischaemic stroke

Spinal cord compression

Syncope

Mental status changes

Urinary retention

Urinary tract obstruction

Pulmonary embolism

Deep vein thrombosis

Hypotension

Subdural haematoma

Pneumonia

100%

80%

60%

40%

20%

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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