Europas førende søgning efter kliniske forsøg

3,3-Diphosphono-1,2-Propanedicarboxylic Acid, Tetrasodium Salt (Dpd)

Clinical trials investigating 3,3-Diphosphono-1,2-Propanedicarboxylic Acid, Tetrasodium Salt (Dpd) are studying PSMA-targeted radioligand therapy in people with prostate cancer. The trials aim to assess response, safety, toxicity, imaging, and surgical outcomes in selected patient groups. Both studies are Phase 2 pilot trials.

Table of contents

Overview of the trials

These studies investigate 3,3-Diphosphono-1,2-Propanedicarboxylic Acid, Tetrasodium Salt (Dpd) in the setting of prostate cancer.[1][2] The trials are testing PSMA-based radioligand therapy and are designed to see how well the treatment works and how safe it is in selected patient groups.[1][2]

Both studies are Phase 2 and both are described as prospective pilot studies.[1][2] They are authorised and have small planned enrolment numbers, which means they are early studies with limited patient groups.[1][2]

Who the trials are for

The first trial includes people with prostate cancer who have biochemical recurrence but no radio-morphological local recurrence after primary treatment given with curative intent.[1] In simple terms, this means the blood test suggests the cancer may have returned, but scans do not yet show a visible local tumor.[1]

The second trial includes people with oligometastatic prostate cancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging, and these patients are planned for radical prostatectomy.[2] Oligometastatic means there are only a small number of spread sites.[2]

These are not broad population studies. They focus on carefully selected patients with specific prostate cancer situations that can be followed closely during treatment and testing.[1][2]

Study design and phase

Both trials are interventional, which means the research team gives a treatment and then measures the results.[1][2] They are not simple observation studies, because the patients receive PSMA-radioligand therapy as part of the study plan.[1][2]

The first study plans to enroll 26 people, and the second study plans to enroll 10 people.[1][2] This small size fits the pilot-study design, where the main goal is to learn whether the approach is promising and feasible in a limited group.[1][2]

The intervention lists include Locametz, LUTETIUM (177LU) ZADAVOTIDE GURAXETAN, and TECEOS Trockenstechampullen as part of radiopharmaceutical preparation and administration in the study setting.[1][2]

What the trials measure

The first trial’s main outcome is PSA response, defined as a PSA decline of at least 50% from the starting value.[1] PSA is a blood marker used to follow prostate cancer, so this outcome checks whether the treatment lowers that marker clearly.[1]

The first trial also measures toxicity, including harmful changes in blood counts, kidney function, and liver function, using CTCAE v5.0 grading.[1] CTCAE is a standard system for describing and grading side effects or treatment-related harm in clinical studies.[1]

The second trial focuses on safety and toxicity of neoadjuvant PSMA-RLT and radical prostatectomy.[2] Neoadjuvant means treatment given before the main surgery.[2]

That second study also looks at PSA response, imaging response, pathological response, and oncological outcomes.[2] Pathological response means what is seen in the removed tissue, while oncological outcomes refer to cancer-related results after treatment.[2]

Trial-by-trial summary

Trial 2024-519348-34-00 studies people with prostate cancer and biochemical but not radio-morphological local recurrence after curative primary therapy.[1] Its main goal is to see whether [177Lu]Lu-PSMAI&T-radioligand therapy can produce a strong PSA drop and what toxicity it causes.[1] The trial is Phase 2, authorised, and plans to enroll 26 participants.[1]

Trial 2024-519377-18-00 studies people with oligometastatic prostate cancer diagnosed by [68Ga]Ga-PSMA-11 PET imaging and planned for radical prostatectomy.[2] It aims to evaluate safety, toxicity, PSA response, imaging response, pathological response, and oncological outcomes after neoadjuvant PSMA-RLT and surgery.[2] The trial is Phase 2, authorised, and plans to enroll 10 participants.[2]

Key terms explained

Biochemical recurrence means a blood test suggests the cancer may be back, even if scans do not show a clear tumor yet.[1]

Radio-morphological recurrence means a recurrence that can be seen on imaging tests.[1]

Radical prostatectomy is surgery to remove the prostate gland.[2]

PSMA PET imaging is a scan method used to find prostate cancer activity in the body.[2]

Radioligand therapy is a treatment approach used in these studies to target prostate cancer in a research setting.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-519348-34-00 Phase 2 Prostate carcinoma with biochemical but not radio-morphological local recurrence Authorised 26
2024-519377-18-00 Phase 2 Oligometastatic prostate carcinoma planned for radical prostatectomy Authorised 10

FAQ

  • What are these trials studying? The trials are studying PSMA-radioligand therapy in prostate cancer. They look at treatment response, safety, toxicity, imaging findings, and some surgical or cancer outcome measures.
  • Who can take part in these studies? One study includes people with prostate cancer and biochemical but not radio-morphological local recurrence after curative primary therapy. The other study includes people with oligometastatic prostate cancer diagnosed by [68Ga]Ga-PSMA-11 PET imaging who are planned for radical prostatectomy.
  • What phase are the trials? Both studies are Phase 2. They are described as prospective pilot studies, which means they are early studies that test the treatment in a small group of patients.
  • What outcomes are being measured? One trial measures PSA response, defined as a PSA drop of at least 50% from baseline, and treatment toxicity, including blood counts, kidney function, and liver function. The other trial measures safety and toxicity, plus PSA, imaging, pathological response, and oncological outcomes.
  • How many people are in these trials? The first study plans to enroll 26 people. The second study plans to enroll 10 people.

Igangværende kliniske forsøg for 3,3-Diphosphono-1,2-Propanedicarboxylic Acid, Tetrasodium Salt (Dpd)

  • Test af ny [177Lu]Lu-PSMAI&T behandling før operation hos mænd med begrænset spredt prostatakræft

    Rekrutterer

    1 1 1
    Undersøgte lægemidler:
    Østrig

  • Ny strålebehandling med [177Lu]Lu-PSMAI&T til mænd med tilbagevendende prostatakræft efter tidligere behandling

    Rekrutterer

    1 1 1
    Undersøgte lægemidler:
    Østrig

Ordliste

  • Prostate cancer: A cancer that starts in the prostate gland, which is part of the male reproductive system.
  • Biochemical recurrence: A rise in a blood marker, such as PSA, that can suggest cancer has returned even when scans do not yet show a clear tumor.
  • Radio-morphological recurrence: Cancer return that can be seen on imaging tests such as scans.
  • Oligometastatic: A small number of cancer spread sites, rather than many spread sites.
  • PET imaging: A scan that helps show where cancer cells may be active in the body.
  • PSMA: A target found on prostate cancer cells that can be used to help guide certain imaging and treatment approaches.
  • Radioligand therapy: A treatment that uses a radioactive substance linked to a targeting molecule to reach cancer cells.
  • PSA: Prostate-specific antigen, a blood test marker used to follow prostate cancer.
  • Toxicity: Harmful effects of a treatment, such as changes in blood counts or organ function.
  • Pathological response: Changes seen in tissue after treatment, usually checked under a microscope.

Referencer

  1. https://clinicaltrials.gov/study/2024-519348-34-00
  2. https://clinicaltrials.gov/study/2024-519377-18-00