Quantitative Unified Assessment of Novel Triplet therapy and Unconventional Maintenance with Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer: A Phase II Pilot Trial

Registry ID

2026-525550-11-00

Source registry

CTIS

Status

Authorised

Phase

PHASE2

Study type

INTERVENTIONAL

Sponsor

Alianza Multidisciplinar Para La Investigacion De Los Tumores Genitourinarios Guard

Enrollment

50

Last update

2026-08-14

Conditions

• Diseases [C] - Male Urogenital Diseases [C12]
• Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Primary outcomes

The primary endpoint for this study is treatment compliance, measured as the total number of cycles administered to each patient. Patients will be categorized in two groups, complete treatment compliance (complete ≥5 cycles of Ra223) and incomplete treatment compliance (complete <5 cycles of Ra223). The proportion of patients in each category and their 95% confidence interval (CI) calculated by Clopper-Pearson will be given.

Locations

• , , Spain

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