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NCT04297410: NALuPROST

177Lu-PSMA-I&T Prior to Radical Prostatectomy for Locally Advanced Disease

Status unknown NA Last updated 5 March 2020
What this trial tests

NA trial testing 177Lu-PSMA-I&T Radionuclide in Prostate Cancer in 5 participants. Status unknown.

Timeline
20 November 2019
Primary endpoint
20 November 2021
20 April 2022

Quick facts

Lead sponsorRabin Medical Center
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment5
Start date20 November 2019
Primary completion20 November 2021
Estimated completion20 April 2022
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Rabin Medical Center

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Despite surgical advances, up to 50% of patients with high-risk locally advanced prostate cancer will die from their disease. Drug therapy before surgery has the potential to improve treatment success by lowering tumor volume in the prostate and treating small metastases. PET PSMA is an advanced imaging technique that allows the identification of areas involved by the tumor in the prostate or in the pelvis. This technique is based on the protein PSMA (prostate-specific membrane antigen) which is located on the tumor cells. The presence of PSMA on tumor cells has been recently used for treatment purposes. A chemical element (Lutetium) that binds to PSMA and emits local radiation can destroy tumors cells. This treatment has been used in patients with advanced metastatic disease and showed promising results. The investigators hypothesized that using these particles can improve long term results in patients who undergo surgery for prostate cancer which has not extensively spread. The investigators will assess both the immediate and long-term impact of this novel treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Analytical performance of aPROMISE: automated anatomic contextualization, detection, and quantification of [<sup>18</sup>F]DCFPyL (PSMA) imaging for standardized reporting.
    Johnsson K, Brynolfsson J, Sahlstedt H, Nickols NG, et al · · 2022 · cited 42× · PMID 34463809 · DOI 10.1007/s00259-021-05497-8
  2. Radionuclide Therapy in Prostate Cancer: from standalone to combination PSMA theranostics.
    Sandhu S, Guo C, Hofman MS. · · 2021 · cited 34× · PMID 34385339 · DOI 10.2967/jnumed.120.243295
  3. &lt;sup&gt;89&lt;/sup&gt;Zr-labeled PSMA ligands for pharmacokinetic PET imaging and dosimetry of PSMA-617 and PSMA-I&amp;T: a preclinical evaluation and first in man.
    Privé BM, Derks YHW, Rosar F, Franssen GM, et al · · 2022 · cited 30× · PMID 34932154 · DOI 10.1007/s00259-021-05661-0
  4. More Than Meets the Eye: Scientific Rationale behind Molecular Imaging and Therapeutic Targeting of Prostate-Specific Membrane Antigen (PSMA) in Metastatic Prostate Cancer and Beyond.
    Hyväkkä A, Virtanen V, Kemppainen J, Grönroos TJ, et al · · 2021 · cited 22× · PMID 34067046 · DOI 10.3390/cancers13092244
  5. Lutetium-177 Labelled PSMA Targeted Therapy in Advanced Prostate Cancer: Current Status and Future Perspectives.
    Seifert KE, Seifert R, Kessel K, Roll W, et al · · 2021 · cited 17× · PMID 34359614 · DOI 10.3390/cancers13153715
  6. Impact of PSMA PET on Prostate Cancer Management.
    Weiner AB, Agrawal R, Valle LF, Sonni I, et al · · 2024 · cited 15× · PMID 38270802 · DOI 10.1007/s11864-024-01181-9
  7. PSMA-RLT in Patients with Metastatic Hormone-Sensitive Prostate Cancer: A Retrospective Study.
    Banda A, Privé BM, Allach Y, Uijen MJM, et al · · 2022 · cited 14× · PMID 36612293 · DOI 10.3390/cancers15010297
  8. PSMA Targeted Molecular Imaging and Radioligand Therapy for Prostate Cancer: Optimal Patient and Treatment Issues.
    Hoshi S, Yaginuma K, Meguro S, Onagi A, et al · · 2023 · cited 10× · PMID 37623010 · DOI 10.3390/curroncol30080529

Verify or expand the search:

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

Other Rabin Medical Center trials

Trials by the same sponsor.

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