A prospective study of oral 5-AMinolevulinic acid for preventing adverse events in patients with localized prostate cancer undergoing low-dose rate BrachythERapy

Phase 2

• Conditions: ocalized prostate cancer; prostate, neoplasm; Prostatic Neoplasms

• Registration Number: JPRN-jRCTs051190077
• Lead Sponsor: Miyake Makito

Brief Summary

Six-month oral administration of 5-aminolevulinic acid phosphate could provide benefit to ameriolate treatment-induced lower urinary symptomes in patients treated with brachytherapy. The 5-aminolevulinic acid phosphate was safe and torelable in prostate cancer patients treated with brachytherapy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-05
• Study Completion: 2021-11-30
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1) Patients undergoing low dose rate brachytherapy for localized prostate cancer of clinical stage, T1-T3N0M0 (excluding those who undergo supplementary extra-beam radiotherapy)
2) Age, 50 to 85 yo
3) ECOG-PS 0 or 1
4) No history of radiotherapy to the pelvic for other malignant diseases
5) Sufficient bone marrow function and organ functions within 60 days before the registration
6) Agreement for enrolment in the study with the signed form

Exclusion Criteria

1) History of allergic reaction to 5-aminolevulinic acid and/or sodium ferrous citrate
2) Patients who undergo supplementary extra beam radiotherapy after low dose rate brachytherapy
3) Patients with clinically significant liver dysfucntion and liver inflammation
4) Patients with porphyria
5) Patients who can not agree with enrollment of the study and can not intake medicine by his own intention
6) Inappropriate for the enrolment by the judgement of the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rinary frequency at 3 months after low dose rate brachytherapy (evaluation with frequency volume chart)

Secondary Outcome Measures

Name	Time	Method
1) Urinary frequency at 1, 6, 12 months after low dose rate brachytherapy (evaluation with frequency volume chart)<br>2) Brachytehrapy-related adverse event (evaluation with CTCAE ver 5)<br>3) Changes of health-related quality of life (SF-8 , EPIC)<br>4) Changes of lower urinary tract symptom- and sexual function-related questionnaires (IPSS, OABSS, IIEF) <br>5) Biochemical recurrence-free survival after brachytherapy<br>6) Salvage hormone therapy-free survival<br>7) Metastatic-free survival<br>8) Cancer-specific survival<br>9) Overall survival<br>10) Safety of oral administration of 5-aminolevulinic acid phosphate with sodium ferrous citrate