Radiotherapy for Prostate Cancer

(ARREST Trial)

EN
MP
Overseen ByMom Phat
Age: Any Age
Sex: Male
Trial Phase: Phase 2
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Must be taking: Bone protective therapy
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach for prostate cancer that has spread and resists regular hormone therapy. The study tests whether combining two types of radiation—one standard and the other more targeted (177Lu-PSMA radioligand therapy)—can better manage bone issues caused by cancer. Suitable candidates for this trial include those already receiving 177Lu-PSMA treatment, particularly if they have cancer spots that might benefit from additional radiation. The goal is to determine if this combined approach can improve outcomes such as quality of life and survival while reducing bone problems within a year. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems you can continue with your existing treatments, especially since the trial involves patients already receiving 177Lu-PSMA therapy.

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

Research shows that 177Lu-PSMA radioligand therapy is generally well-tolerated by patients with prostate cancer. Studies have found this treatment to be safe and effective, helping patients live longer and slowing disease progression. Some studies have noted that side effects are manageable, regardless of dose.

External beam radiotherapy (EBRT) has also undergone safety studies. It has been used for many years to treat prostate cancer, and patients usually report good results. Sometimes, EBRT is combined with other treatments, and this approach has been safe for patients with advanced prostate cancer.

Since this trial is in the early stages, the combination of 177Lu-PSMA and EBRT requires further safety testing. However, existing research on both treatments separately suggests they are generally well-tolerated. Prospective participants should discuss potential risks and benefits with their doctor.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about 177Lu-PSMA radioligand therapy for prostate cancer because it targets a specific protein called PSMA, found in high amounts on prostate cancer cells. Unlike traditional treatments like surgery, radiation, or hormone therapy, 177Lu-PSMA delivers radiation directly to cancer cells, minimizing damage to healthy tissues. This precision could mean fewer side effects and potentially more effective outcomes for patients. Additionally, combining this targeted approach with external beam radiotherapy may enhance its effectiveness, offering a promising new option for those with advanced prostate cancer.

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

Research has shown that 177Lu-PSMA radioligand therapy (RLT) effectively treats metastatic castration-resistant prostate cancer (mCRPC). Studies have found that it can significantly reduce prostate-specific antigen (PSA) levels, indicating decreased cancer activity. Many patients experience less pain and live longer with this treatment. The therapy is generally well-tolerated, with few side effects. In this trial, one group of participants will receive RLT alone, while another group will receive a combination of RLT and external beam radiotherapy (EBRT). EBRT has also proven successful in treating prostate cancer, leading to high survival rates and positive patient feedback. Combining RLT with EBRT might enhance effectiveness in targeting cancer and improving patient outcomes.13678

Who Is on the Research Team?

CM

Cynthia Menard, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for men with metastatic castration-resistant prostate cancer (mCRPC) who can undergo radioligand therapy and have tumors suitable for external beam radiotherapy. Patients must be part of the PERa cohort, able to receive standard-of-care 177Lu-PSMA, and have targetable metastases on imaging.

Inclusion Criteria

I am on medication to protect my bones.
I am fully active or can carry out light work.
I am receiving 177Lu-PSMA treatment for advanced prostate cancer.
See 1 more

Exclusion Criteria

No exclusions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either SOC 177Lu-PSMA therapy alone or combined 177Lu-PSMA plus EBRT boost, with a maximum of 6 cycles

12 weeks
FDG-PET at study entry and SPECT-CT after each cycle

Follow-up

Participants are monitored for skeletal related events, overall survival, PSA response, toxicity, and quality of life

12 months
Regular monitoring visits

What Are the Treatments Tested in This Trial?

Interventions

  • 177Lu-PSMA radioligand therapy
  • External Beam Radiotherapy

Trial Overview

The ARREST trial tests if adding external beam radiotherapy to standard radioligand therapy improves outcomes in mCRPC. It's a phase 2 study where patients are randomly chosen to get either just the standard treatment or combined with targeted radiation boosts.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: External beam added to radioligand radiotherapyExperimental Treatment1 Intervention
Group II: SOC radioligand therapyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

Varian, a Siemens Healthineers Company

Industry Sponsor

Trials
35
Recruited
7,200+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41307700/

Efficacy, toxicity, and clinical outcomes of 177Lu-PSMA ...

Conclusions: 177Lu-PSMA-617 at 5.5 GBq per cycle was safe and effective, achieving survival comparable to studies using 7.4 GBq with fewer ...

Lutetium-177–PSMA-617 for Metastatic Castration ...

This radioligand therapy has been associated with encouraging biochemical and radiographic response rates, reduced pain, and low toxicity in multiple early- ...

[177Lu]Lu-PSMA-Radioligand Therapy Efficacy Outcomes in ...

Specifically, in taxane-naïve patients receiving [177Lu]Lu-PSMA-RLT, the odds of having a PSA response were 1.8 times better than in taxane- ...

A Meta-Analysis and Meta-Regression of the Efficacy, ...

In some studies, [177Lu]Lu-PSMA therapy has been shown to decrease the level of prostate-specific antigen (PSA) by at least 50%, with a favourable toxicity ...

Outcomes following external beam radiotherapy to the ...

5-year overall survival and prostate cancer-specific survival were 74.4 and 89.1% respectively. 5-year failure-free survival was 55.4%; with 5-year biochemical ...

Long-term safety outcomes of 177Lu-PSMA-617 in patients ...

It is important to further characterize long-term safety outcomes in 177 Lu-PSMA-617–treated patients, with particular regard to potential treatment-related ...

Safety and Efficacy of Lutetium-177 PSMA Therapy for ...

[177Lu]Lu-PSMA-617 is a radioactive drug that binds to PSMA and delivers radiation directly to prostate cancer cells. This can kill the cancer cells while ...

AUA 2025: Health-Related Quality of Life, Pain and Safety ...

In the PSMAfore study, taxane-naive, PSMA-positive patients with mCRPC who received 177Lu-PSMA-617 had prolonged radiographic progression-free survival versus ...