64 Participants NeededMy employer runs this trial

Lutetium Lu 177 Treatment for Prostate Cancer

MS
Overseen ByMichael Schweizer, MD
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: University of Washington
Must be taking: LHRH analogue
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called lutetium Lu 177, a type of radiopharmaceutical therapy, for prostate cancer that has spread and no longer responds to standard hormone therapy. Researchers aim to determine if a blood test measuring circulating tumor DNA (ctDNA) can guide decisions to stop this treatment early if it proves ineffective. Patients with low ctDNA levels will continue the treatment, while those with high levels might switch to a different therapy. Men with prostate cancer that has spread to areas like bones and who have tried at least one unsuccessful hormone therapy may be suitable candidates. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, patients treated with lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) experienced common side effects such as tiredness, dry mouth, nausea, low red blood cell count (anemia), loss of appetite, and constipation. This treatment can also damage genetic information and potentially cause cancer, so careful use is essential.

Research has shown that docetaxel, another treatment option, is generally considered safe but can have serious side effects. In one study, 34% of patients receiving docetaxel required hospitalization, and about 16.5% experienced febrile neutropenia, a condition involving a low white blood cell count and fever that requires immediate medical care.

Both treatments carry risks but have been used successfully to treat prostate cancer. Discussing these risks with healthcare providers is crucial to determine the best option based on individual health conditions.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Lutetium Lu 177 Vipivotide Tetraxetan because it offers a targeted approach for treating prostate cancer. Unlike traditional chemotherapy, which affects both cancerous and healthy cells, this treatment uses a radioactive compound that specifically targets and binds to PSMA, a protein commonly found on prostate cancer cells, delivering radiation directly to the tumor. This targeted mechanism could potentially minimize side effects and improve treatment effectiveness. Additionally, the use of ctDNA testing helps tailor the treatment to each patient's response, potentially leading to more personalized and effective care.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that lutetium Lu 177 vipivotide tetraxetan, a treatment in this trial, effectively treats advanced prostate cancer that no longer responds to hormone therapy. In one study, 68.9% of patients experienced a significant drop in PSA levels (a protein made by prostate cells) by 10% or more, and 55.6% saw a reduction of 50% or more. This treatment also helped patients live longer without their cancer worsening. Meanwhile, docetaxel, another treatment option in this trial, improved survival rates and reduced deaths specifically from prostate cancer by 70%. Both treatments have strong potential to help manage advanced prostate cancer.678910

Who Is on the Research Team?

MS

Michael Schweizer, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for people with prostate cancer that has spread and no longer responds to hormone therapy (castration-resistant). Participants must have metastatic disease and be eligible for treatment with Lutetium Lu 177 vipivotide tetraxetan.

Inclusion Criteria

I am a male and at least 18 years old.
Willing and able to provide informed consent
My prostate cancer is growing despite low testosterone levels.
See 13 more

Exclusion Criteria

I do not have any serious or unstable health or mental conditions that affect my safety or consent.
I have not had systemic therapy or radiotherapy in the past 2 weeks, except LHRH analogue.
Poor medical risk due to serious uncontrolled medical disorder or active uncontrolled infection
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

PSMA PET scan, blood sample collection

Treatment Cycles 1 and 2

Participants receive 177Lu-PSMA-617 IV every 6 weeks for up to 2 cycles, with ctDNA TF testing at baseline and C2D1

12 weeks
2 visits (in-person) for IV treatment, additional visits for blood sample collection

Treatment Cycle 3+ Arm I

Participants with undetectable ctDNA TF continue 177Lu-PSMA-617 IV every 6 weeks

6 weeks per cycle
1 visit (in-person) per cycle for IV treatment

Treatment Cycle 3+ Arm II

Participants with detectable ctDNA TF receive docetaxel IV every 3 weeks

3 weeks per cycle
1 visit (in-person) per cycle for IV treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 1 year
Follow-up every 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Docetaxel
  • Lutetium Lu 177 Vipivotide Tetraxetan

Trial Overview

The study tests if measuring tumor DNA in the blood (ctDNA) can help doctors decide when to stop a targeted radiation treatment called Lutetium Lu 177 vipivotide tetraxetan early. Other procedures include scans, blood tests, and possibly chemotherapy like docetaxel.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Cycles 1 and 2 (177Lu-PSMA-617, ctDNA testing)Experimental Treatment6 Interventions
Group II: Cycle 3+ Arm I (177Lu-PSMA-617)Active Control5 Interventions
Group III: Cycle 3+ Arm II (docetaxel)Active Control5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Institute for Prostate Cancer Research (IPCR)

Collaborator

Trials
1
Recruited
20+

Citations

Docetaxel in prostate cancer: a familiar face as the new ... - PMC

A total of 2993 patients were analyzed for OS, obtaining a HR of 0.77 [95% CI (0.68–0.87)] with a 10% absolute improvement in survival at 4 years.

Mortality Risk for Docetaxel-Treated, High-Grade Prostate ...

Docetaxel has been shown to prolong overall survival (OS) in men with castrate-resistant and castrate-sensitive metastatic prostate cancer.

Docetaxel Found to Be Significantly Associated With ...

SOC plus docetaxel was associated with a significant 70% reduction in prostate cancer-specific mortality (PCSM) and a nearly halved all-cause ...

Long-Term Outcomes of a Phase I Trial of Weekly ...

This regimen produced a 10-year overall survival of 68% with a 10-year metastasis-free survival of 58%. Grade >2 toxicity was minimal. These limited data ...

Docetaxel plus Prednisone or Mitoxantrone ...

treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain, serum PSA level, and quality of life,

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28940952/

Real-world uptake, safety profile and outcomes of ...

Of the 270 eligible patients, 103 received docetaxel (38.1%). 35 patients (34%) were hospitalised and there were 17 episodes of febrile neutropenia (16.5%). ...

Efficacy and Safety of Docetaxel in Elderly Patients With ...

In summary, our results suggest that, in the real-world setting, docetaxel continues to be a reasonable option, which has a good safety profile, ...

Dr. Oh on the Safety Profile of Docetaxel in Prostate Cancer

William K. Oh, MD, discusses the safety profile of docetaxel when administered to patients with prostate cancer.

Evolving Role of Docetaxel in Metastatic Prostate Cancer

Early results showed that adding docetaxel to ADT improved survival by 24% (HR = 0.76; 95% CI, 0.63-0.91; P = .003) and failure-free survival by 38% (HR = 0.62 ...

Docetaxel chemotherapy plus androgen-deprivation therapy ...

The data presented here analyze the safety and efficacy of DTX chemotherapy for 153 HVD-mHSPC patients from January 2018 to December 2019