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

JRCT ID: jRCTs051190077

Registered date:05/12/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Localized prostate cancer
• Date of first enrollment: 05/12/2019
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Oral administration of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate

Outcome(s)

• Primary Outcome: Urinary frequency at 3 months after low dose rate brachytherapy (evaluation with frequency volume chart)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 85age old
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Miyake Makito
• Source(s) of Monetary Support: SBI Pharmaceuticals CO., Ltd.