A Comparison of the Effectiveness of Synergistic Treatment by androgen deprivation therapy and Lutetium-177–labeled Prostate-specific Membrane Antigen–targeted Radioligand therapy with chemotherapy and androgen deprivation therapy on biochemical response in High-volume Metastatic Prostate Cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241124063822N2

Enrollment

Registered

2026-02-17

Start date

2026-02-20

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-volume Hormone-sensitive Metastatic Prostate Cancer. Malignant neoplasm of prostate

Interventions

Intervention 1: Intervention arm: antiandrogen therapy, lutetium therapy, androgen receptor pathway inhibitor, and supportive care. Antiandrogen therapy: continuous administration of an LHRH agonist o

produced by Pars Isotope Company) every 8–10 weeks, continued until a therapeutic response is observed (PSA reduction to below 0.2 ng/mL, improvement of bone pain, etc.) or until adverse effects occur

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Metastatic prostate cancer patients who underwent ADT Informed consent of patients

Exclusion criteria

Exclusion criteria: Special medical conditions Any decline in hematologic parameters Any relative or absolute contraindication of treatment with radiopharmaceuticals

Design outcomes

Primary

Measure	Time frame
The serum PSA level decline. Timepoint: Every 8-10 weeks. Method of measurement: Blood test with the special kit.	—

Secondary

Measure	Time frame
Lesions uptake. Timepoint: Each 8-10 weeks. Method of measurement: Lutetium-PSMA scan (SPECT/CT scan).;Bone pain. Timepoint: Each 8-10 weeks. Method of measurement: Patients histort taking- patients self-scoring.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSalman Soltani

Mashhad University of Medical Sciences

SoltaniS@mums.ac.ir+98 51 3854 3031

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026