NCT05230251: ROADSTER

Radioligand fOr locAl raDiorecurrent proStaTe cancER

Completed Phase 1, PHASE2 Last updated 12 September 2025

What this trial tests

Phase 1, PHASE2 trial testing 177Lu-PNT2002 in Prostate Cancer in 3 participants. Completed in 31 December 2024.

Timeline

17 March 2022

Primary endpoint
25 September 2023

31 December 2024

Quick facts

Lead sponsor	Glenn Bauman
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	17 March 2022
Primary completion	25 September 2023
Estimated completion	31 December 2024
Sites	1 location across Canada

Drugs / interventions tested

• 177Lu-PNT2002 — full drug profile →
• High Dose Radiation

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Glenn Bauman — full company profile →

Who can join

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

Sponsor's own description

Approximately 50-60% of men undergoing salvage brachytherapy post cancer recurrence to the prostate have the disease controlled at 5 years. This study aims to integrate a local treatment to the prostate (brachytherapy) with a treatment involving 177Lutetium (Lu)- Prostate-Specific Membrane Antigen (PSMA) therapy. Differently than brachytherapy, 177-Lutetium-PSMA is thought to have its effect not only to the cancer cells within the prostate, but also to cancer cells located elsewhere in the body. Thus, the idea here is that by adding 177Lutetium (Lu)- PSMA early in the course of treatment we may be able to inactivate potential metastatic cells outside the prostate, while the prostate cancer within this organ still treated by the combination of brachytherapy and 177-Lutetium-PSMA.

Publications & conference data

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

1. Status of PSMA-targeted radioligand therapy in prostate cancer: current data and future trials.
   Jang A, Kendi AT, Sartor O. · · 2023 · cited 63× · PMID 36895851 · DOI 10.1177/17588359231157632
2. Peptide Drug Conjugates and Their Role in Cancer Therapy.
   Heh E, Allen J, Ramirez F, Lovasz D, et al · · 2023 · cited 54× · PMID 36614268 · DOI 10.3390/ijms24010829
3. Innovation in Radionuclide Therapy for the Treatment of Prostate Cancers: Radiochemical Perspective and Recent Therapeutic Practices.
   Deshayes E, Fersing C, Thibault C, Roumiguie M, et al · · 2023 · cited 11× · PMID 37370743 · DOI 10.3390/cancers15123133
4. Prostate-Specific Membrane Antigen-Targeted Therapy in Prostate Cancer: History, Combination Therapies, Trials, and Future Perspective.
   Mattana F, Muraglia L, Barone A, Colandrea M, et al · · 2024 · cited 9× · PMID 38730595 · DOI 10.3390/cancers16091643
5. Novel radionuclide therapy combinations in prostate cancer.
   Inderjeeth AJ, Iravani A, Subramaniam S, Conduit C, et al · · 2023 · cited 9× · PMID 37547444 · DOI 10.1177/17588359231187202
6. PSMA theragnostics for metastatic castration resistant prostate cancer.
   Song H, Guja KE, Iagaru A. · · 2022 · cited 8× · PMID 35659674 · DOI 10.1016/j.tranon.2022.101438
7. The use of Lutetium-177 PSMA radioligand therapy with high dose rate brachytherapy for locally recurrent prostate cancer after previous definitive radiation therapy: a randomized, single-institution, phase I/II study (ROADSTER).
   Mendez LC, Dhar A, Laidley D, Moussa M, et al · · 2023 · cited 7× · PMID 37081426 · DOI 10.1186/s12885-023-10851-0
8. A Treatment Paradigm Shift: Targeted Radionuclide Therapies for Metastatic Castrate Resistant Prostate Cancer.
   Parent EE, Kase AM. · · 2022 · cited 6× · PMID 36077820 · DOI 10.3390/cancers14174276