36 Participants Needed

Radioligand Therapy for Prostate Cancer

Recruiting at 9 trial locations
NP
Overseen ByNovartis Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gastrin Releasing Peptide Receptor (GRPR) between the start and after the completion of radioligand therapy (RLT). Study will use radioligand imaging (RLI) to determine predominantly expressed target on the surface of tumor cells. Based on predominant expression of target, corresponding RLT targeting PSMA, SSTR2, or GRPR RLT will be given for up to 6 cycles every 6 weeks as intravenous (i.v.) injection in participants with metastatic neuroendocrine prostate cancer (mNEPC).

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions controlling for proton-pump inhibitors (PPI) drugs among concomitant treatments, which suggests some medications might need adjustment. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment for prostate cancer?

The treatment using 177Lu-PSMA-617 has shown effectiveness in prostate cancer by reducing prostate-specific antigen (PSA) levels by more than 50% in 30-60% of patients with advanced prostate cancer, with low toxicity. This suggests it can be a promising option for patients who have exhausted other standard therapies.12345

Is radioligand therapy for prostate cancer generally safe for humans?

Radioligand therapy for prostate cancer, such as PSMA-targeted treatments, generally has a favorable safety profile. Common side effects include dry mouth and fatigue, while serious blood-related side effects are rare. However, there are reports of delayed kidney issues in some patients.14678

What makes PSMA, SSTR2, and GRPR Targeted Radioligand Therapy unique for prostate cancer treatment?

This treatment is unique because it uses radioligands (radioactive substances) that specifically target proteins like PSMA, SSTR2, and GRPR found on prostate cancer cells, allowing for precise delivery of radiation to the cancer cells while sparing normal tissues. This targeted approach is novel compared to traditional therapies and is being explored for its effectiveness in both hormone-sensitive and castration-resistant prostate cancer.257910

Research Team

NP

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for individuals with metastatic neuroendocrine prostate cancer showing specific markers. They must have tumors visible on PET scans, progressing metastases without PSA increase, and certain elevated blood markers. Participants need controlled testosterone levels, recovery from previous treatments to a mild severity level, good bone marrow and organ function, and an ECOG status of 2 or less.

Inclusion Criteria

My prostate cancer has spread and shows neuroendocrine features.
My cancer shows positive on specific PET scans and my testosterone is at castrate level.
I have recovered from major side effects of my previous treatments.
See 2 more

Exclusion Criteria

I have not had radioligand therapy in the last 6 months.
I have had targeted radioligand therapy before.
I am currently using specific medications.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 weeks
3 visits (in-person) for radioligand imaging

Treatment

Participants receive up to 6 cycles of radioligand therapy targeting PSMA, SSTR2, or GRPR every 6 weeks

36 weeks
6 visits (in-person) for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
1 visit (in-person) for safety follow-up

Long-term Follow-up

Participants are followed until radiographic disease progression, death, lost to follow-up, or withdrawal of consent

Every 12 weeks for selected adverse events

Treatment Details

Interventions

  • PSMA, SSTR2 and GRPR Targeted Radioligand Therapy
Trial OverviewThe study tests the efficacy of targeted radioligand therapy (RLT) using [68Ga]Ga-PSMA-11, [68Ga]GA-DOTA-TATE, or [68Ga]Ga-NeoB based on tumor cell surface targets PSMA, SSTR2 or GRPR. It involves up to six cycles every six weeks of intravenous injections in participants with mNEPC.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: SSTR2-predominant NEPCExperimental Treatment9 Interventions
Group II: PSMA-predominant NEPCExperimental Treatment6 Interventions
Group III: GRPR-predominant NEPCExperimental Treatment6 Interventions

PSMA, SSTR2 and GRPR Targeted Radioligand Therapy is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as [177Lu]Lu-PSMA-617 for:
  • Metastatic castration-resistant prostate cancer (mCRPC)
🇺🇸
Approved in United States as [177Lu]Lu-PSMA-617 for:
  • Metastatic castration-resistant prostate cancer (mCRPC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

177Lutetium radioligand therapy is an effective treatment for metastatic, castration-resistant prostate cancer, showing a favorable safety profile, making it a valuable option for patients.
Ongoing research is exploring the use of this therapy in earlier stages of prostate cancer, as well as the development of new ligands and isotopes, which could enhance treatment efficacy and minimize side effects.
[New tracers and combinations in radioligand therapy for prostate cancer].Tauber, R., Lunger, L., Eiber, M., et al.[2023]
In a study of 135 prostate cancer patients, those with high tumor loads showed significantly reduced uptake of Ga-68-PSMA-11 in critical organs like the lacrimal and salivary glands, which could impact treatment planning for radioligand therapy (RLT).
The findings suggest that individualizing therapy protocols based on diagnostic PSMA PET imaging could enhance the efficacy and safety of Lu-177-labeled PSMA-ligand therapy, as reduced tracer uptake in dose-limiting organs may affect treatment outcomes.
Uptake of PSMA-ligands in normal tissues is dependent on tumor load in patients with prostate cancer.Gaertner, FC., Halabi, K., Ahmadzadehfar, H., et al.[2018]
In a patient with metastatic castration-resistant prostate cancer (mCRPC), four cycles of radioligand therapy (RLT) using 177Lu-PSMA I&T resulted in over 97% destruction of metastatic tumors, indicating high efficacy of this treatment.
The study highlights the need for individualized dosimetry to account for variations in tumor response and suggests that measuring 177Lu-PSMA activity concentrations could improve routine dosimetry practices, while also noting that the first cycle of RLT has the most significant impact on treatment outcomes.
Radiomics Analysis for 177Lu-DOTAGA-(l-y)fk(Sub-KuE) Targeted Radioligand Therapy Dosimetry in Metastatic Prostate Cancer-A Model Based on Clinical Example.Kelk, E., Ruuge, P., Rohtla, K., et al.[2021]

References

[New tracers and combinations in radioligand therapy for prostate cancer]. [2023]
Uptake of PSMA-ligands in normal tissues is dependent on tumor load in patients with prostate cancer. [2018]
Radiomics Analysis for 177Lu-DOTAGA-(l-y)fk(Sub-KuE) Targeted Radioligand Therapy Dosimetry in Metastatic Prostate Cancer-A Model Based on Clinical Example. [2021]
[PSMA-targeted radioligand therapy in prostate cancer]. [2021]
Experimental 177Lu-PSMA-617 radioligand therapy in a patient with extended metastasized leiomyosarcoma. [2021]
Delayed Nephrotoxicity After 225Ac-PSMA-617 Radioligand Therapy. [2023]
Early side effects and first results of radioligand therapy with (177)Lu-DKFZ-617 PSMA of castrate-resistant metastatic prostate cancer: a two-centre study. [2022]
Delayed response after repeated 177Lu-PSMA-617 radioligand therapy in patients with metastatic castration resistant prostate cancer. [2021]
PSMA-RLT in Patients with Metastatic Hormone-Sensitive Prostate Cancer: A Retrospective Study. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
177Lu-PSMA Radioligand Therapy for Prostate Cancer. [2022]