50 Participants Needed

PSMA-PET Scans for Prostate Cancer

RL
Overseen ByRose Li, MD, PhD
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 how special imaging scans (PSMA-PET) and a blood test (ctDNA) can track prostate cancer progression and response to radiation therapy. It aims to determine if these methods can detect cancer changes earlier than traditional tests. Participants might receive treatments such as hormone therapy (androgen deprivation therapy, ADT, and androgen receptor signaling inhibitors, ARSI) combined with targeted radiation to cancer spots. Ideal candidates have prostate cancer with up to five areas of spread outside the pelvis and a rising PSA level, a marker used to track prostate cancer. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the study team to get a clear answer.

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

Research shows that Androgen Deprivation Therapy (ADT) is usually well-tolerated and can help men with prostate cancer live longer. However, some people experience side effects like tiredness and hot flashes.

For Androgen Receptor Signaling Inhibitors (ARSIs), research demonstrates they greatly improve outcomes for prostate cancer patients, though they carry an increased risk of heart-related issues. Patients should be aware of these risks.

This clinical trial is in Phase 2, indicating that the treatment has shown some safety in earlier trials but is still under study to better understand its safety. Those considering participation should discuss potential side effects with their doctor.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for prostate cancer because they combine advanced imaging with targeted therapies for more precise intervention. Unlike traditional treatments that might broadly target cancer, this approach uses PSMA-PET scans to detect and monitor specific oligometastatic lesions, enabling more targeted ablative intent radiation therapy (RT). Additionally, the combination of androgen deprivation therapy (ADT) and androgen receptor signaling inhibitors (ARSI) with RT provides a multi-faceted approach that aims to control cancer more effectively by attacking it from different angles. This method could lead to improved outcomes for patients with limited metastatic disease, offering a potentially more effective alternative to current standard treatments.

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

This trial will compare different treatment approaches for prostate cancer. Studies have shown that androgen deprivation therapy (ADT), which participants in this trial may receive, can extend survival by lowering hormone levels that promote cancer growth. In this trial, some participants will receive ADT combined with radiotherapy, which research indicates increases the chances of living longer without cancer spreading.

Another treatment option in this trial is androgen receptor signaling inhibitors (ARSI), which have also shown promise. These inhibitors can lower PSA levels, indicating cancer activity, more effectively than some other treatments. Overall, these treatments have improved survival rates and helped manage prostate cancer more effectively.24678

Who Is on the Research Team?

RL

Rose Li, MD, PhD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with controlled prostate cancer and rising PSA levels, who can undergo radiotherapy. They must agree to use birth control or abstain from sex, have a good performance status (KPS ≥ 70 or ECOG 0-1), and measurable disease by imaging. Not eligible if on continuous ADT, allergic to similar compounds, unable to follow study procedures, or have certain infections.

Inclusion Criteria

Agreement to use effective birth control or abstain from heterosexual activity
Documented informed consent of the participant or legally authorized representative
I am 18 years old or older.
See 7 more

Exclusion Criteria

I plan to undergo hormone therapy for prostate cancer indefinitely.
History of allergic reactions to compounds of similar composition to study agent
Contraindications to undergo PSMA-PET
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy Treatment

Participants receive ablative-intent radiotherapy to metastatic sites

6-12 months
Regular visits for radiotherapy sessions

Monitoring

Evaluate PSMA-PET response and ctDNA changes at 6 and 12 months

Up to 5 years
PET scans at 6 and 12 months, regular blood tests for ctDNA

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ADT
  • ARSI
Trial Overview The study tests how PSMA-PET scans and ctDNA monitoring can detect early prostate cancer progression and response after targeted radiotherapy. It looks at PET scan responses at different times compared to PSA changes and explores the link between scan findings and ctDNA changes post-radiotherapy.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Recurrent prostate ca with oligometastatic disease who decline ADT/ARSIExperimental Treatment1 Intervention
Group II: Recurrent disease with oligometastatic disease treated with ADT+ablative intent RTExperimental Treatment1 Intervention
Group III: De novo oligometastatic disease treated with ADT+ARSI+ablative intent RTExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36710205/
Effects of Androgen Deprivation Therapy on Prostate Cancer ...We analysed the effectiveness of androgen deprivation therapy (ADT) for localised prostate cancer among patients, defined by the relative ...
Short-term Androgen Deprivation Therapy and High-dose ...In GETUG 14 evaluating the benefit of ADT in patients receiving high-dose RT, we showed that STADT improves the 5-yr rate DFS for patients with ...
Balancing Hormone Therapy: Mitigating Adverse Effects of ...Treatment advances including ADT have led to improvements in PCa management and survival, with trials reporting median survival of over 6 years ...
Clinical efficacy of different androgen deprivation therapies for ...This study evaluated the clinical efficacy of different androgen deprivation therapies in the treatment of PCa from the perspective of DCE-MRI
Androgen deprivation therapy use and duration with ...The addition of ADT to radiotherapy significantly improved metastasis-free survival (HR 0·83 [95% CI 0·77–0·89], p<0·0001), as did adjuvant ADT ...
a systematic review and network meta-analysis - PMCThis systematic review and network meta-analysis aimed to assess the comparative effectiveness and safety profiles of current combination ...
Apalutamide/ADT Improves Long-Term Outcomes in ...Apalutamide with ADT improved metastasis-free survival and reduced castration-resistant prostate cancer risk in biochemically recurrent prostate ...
Improved survival of patients with newly diagnosed ...An intensified, multimodal treatment approach including RP can lead to excellent survival outcomes in patients with newly diagnosed omPCa.
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