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

Conditions

Localized prostate cancer prostate, neoplasm

Miyake M, Tanaka N, Ohnishi K, Nakai Y, Anai S, Yamaki K, Asakawa I, Nishimura N, Fujii T, Isohashi F, Fujimoto K.

2024-11-012 citations

A prospective, single-arm trial of fluorescent ureteroscopy-assisted thulium-holmium:YAG dual laser ablation for upper urinary tract cancer: Study protocol of the FLUAM trial.

Miyake M, Yoshida T, Nishimura N, Oda Y, Shimizu T, Nakahama T, Hori S, Morizawa Y, Gotoh D, Nakai Y, Anai S, Torimoto K, Fujii T, Tanaka N, Fujimoto K.

2022-03-025 citations

10.1016/j.conctc.2022.100902

A prospective study of oral 5-aminolevulinic acid to prevent adverse events in patients with localized prostate cancer undergoing low-dose-rate brachytherapy: Protocol of the AMBER study.

Miyake M, Tanaka N, Asakawa I, Yamaki K, Inoue T, Suzuki S, Hori S, Nakai Y, Anai S, Torimoto K, Toritsuka M, Nakagawa H, Tsukamoto S, Fujii T, Ohbayashi C, Hasegawa M, Kasahara M, Fujimoto K.

2020-06-173 citations

10.1016/j.conctc.2020.100593

Interventions

Oral administration of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate

Aminolevulinic Acid

5-aminolevulinic acid, Ferrous Compounds

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Urinary frequency at 3 months after low dose rate brachytherapy (evaluation with frequency volume chart)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Contacts

Public ContactMakito Miyake

Nara Medical University Hospital

makitomiyake@yahoo.co.jp+81-744-22-3051

Outcome results

None listed