Immediate results of perineal implantation of a prostate-rectum biodegradable spacer

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Abstract

Aim. To evaluate the immediate results of perineal implantation of a biodegradable spacer based on stabilized hyaluronic acid (SНA) of non-animal origin as a way to optimize radiation treatment of prostate cancer.

Materials and methods. The study included 48 patients with verified low and intermediate risk prostate cancer per NCCN (National Comprehensive Cancer Network) who received five-fraction stereotactic radiotherapy as radical treatment. Prior to radiotherapy, all patients underwent insertion of a prostate-rectum biodegradable spacer (PRBS) based on synthetic SHA in the volume of 4–8 mL.

Results. There were no allergic and inflammatory reactions of tissues to the chemical composition of the implanted PRBS. Despite the invasive nature of the procedure, we did not observe any cases of infectious complications.

SНA used in the study demonstrated high levels of hydration (swelling) equal to 24.4 ± 1.5 (20.7–27.3) %, as well as temporal and spatial stability, which determined its optimal characteristics for use as a radiotherapeutic spacer. In all 48 patients, the projected distance (≥1 cm) between the prostate gland and the anterior wall of the rectum was achieved before the start of irradiation. The administration of 4 mL of SНA made it possible to achieve optimal symmetry of the formed space only in one (16.7 %) patient. An increase in the implant volume of the polymer to 6 mL increased the number of such cases to 28.6 %, and after injection of 8 mL it increased to 57 %.

The use of PRBS made it possible to reduce radiation dose to the rectum from 21.5 % (D0.1cc (dose per 0.1 cm3 of rectum)) (р <0.0001) to 92.8 % (V75 % (volume receiving 75 % or more of the prescribed dose)) (р <0.0001). Dose reduction for one of the most clinically validated parameters – D2cc (dose to 2 cm3 of rectum)) was 31.5 % (р <0.0001) on average.

Conclusion. Perineal implantation of a non-animal SНA (Russia) as a radiotherapy spacer in patients with prostate cancer demonstrates excellent safety and efficacy profiles.

About the authors

R. V. Novikov

N.N. Petrov National Medical Research Center of Oncology, Ministry of Health of Russia; S.M. Kirov Military Medical Academy, Ministry of Defense of Russia

Author for correspondence.
Email: novikov-spb@mail.ru
ORCID iD: 0000-0003-1873-1293

Roman Vladimirovich Novikov

68 Leningradskaya St., Pesochnyy, Saint Petersburg 197758; 6 Akademika Lebedeva St., Saint Petersburg 194044

Russian Federation

V. K. Karandashov

S.M. Kirov Military Medical Academy, Ministry of Defense of Russia

ORCID iD: 0009-0001-5155-9491

6 Akademika Lebedeva St., Saint Petersburg 194044

Russian Federation

T. V. Zhivulina

Terlazurra LLC

225/1 Kommunarov St., 350000 Krasnodar

Russian Federation

O. I. Ponomareva

N.N. Petrov National Medical Research Center of Oncology, Ministry of Health of Russia

ORCID iD: 0000-0002-8314-3722

68 Leningradskaya St., Pesochnyy, Saint Petersburg 197758

Russian Federation

I. A. Burovik

S.M. Kirov Military Medical Academy, Ministry of Defense of Russia

ORCID iD: 0000-0002-4714-1228

6 Akademika Lebedeva St., Saint Petersburg 194044

Russian Federation

S. A. Tyatkov

S.M. Kirov Military Medical Academy, Ministry of Defense of Russia

ORCID iD: 0000-0002-1877-8852

6 Akademika Lebedeva St., Saint Petersburg 194044

Russian Federation

A. V. Kulish

S.M. Kirov Military Medical Academy, Ministry of Defense of Russia

ORCID iD: 0000-0001-8274-4967

6 Akademika Lebedeva St., Saint Petersburg 194044

Russian Federation

V. V. Protoshchak

S.M. Kirov Military Medical Academy, Ministry of Defense of Russia

ORCID iD: 0000-0002-4996-2927

6 Akademika Lebedeva St., Saint Petersburg 194044

Russian Federation

G. A. Lyasovich

Clinical Hospital of the Medical Unit of the Ministry of Internal Affairs of Russia for the City of St. Petersburg and the Leningrad Region

2 Kultury Prospekt, Saint Petersburg 194291

Russian Federation

S. N. Novikov

N.N. Petrov National Medical Research Center of Oncology, Ministry of Health of Russia

ORCID iD: 0000-0002-7185-1967

68 Leningradskaya St., Pesochnyy, Saint Petersburg 197758

Russian Federation

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