HDR Brachytherapy vs SABR in Early-intermediate Prostate Cancer

NCT04870567 | Unknown

• 1 other identifier: 03
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This is single center prospective phase 2 randomized trial aiming to compare biochemical and clinical relapse free survival and toxicity profiles of stereotactic body radiotherapy (SBRT) versus high dose rate brachytherapy (HDRB) for localized low- and intermediate risk prostate cancer patients.

Conditions

Biochemical Relapse Free Survival; Complications Rates (Erectile Dysfunction, GI, GU Complications)

Keywords

brachytherapy; stereotactic ablative radiotherapy; survival; complications

Outcome Measures

Primary Outcomes (2)

• Number of grade 3-5 Adverse Events Assessed by Common Terminology Criteria for Adverse Events CTCAE v5

  To evaluate frequency of grade 3-5 toxicity in patients treated by high dose rate brachutherapy (arm 1) and stereotactic ablative radiotherapy (arm 2)

  5 years after treatment

• Change in the proportion of patients with moderate and severe erectile dysfunction

  Assessed by International Index of Erectile Function (IIEF)

  3, 6, 12, 18, 24 and every 6 months through 5 years

Secondary Outcomes (1)

• Biochemical relapse free survival

  5 years after treatment

Study Arms (2)

High dose rate brachytherapy

ACTIVE COMPARATOR

After spinal anesthesia steel or plastic needle placement performed under TRUS guidance. Pre- and post-insertion ultrasound based planning is obligatory in all cases. Two fractions of 13Gy are delivered with 2 separate implantations and 2-3 weeks interval. The CTV was defined as the prostate capsule with 1mm (low-risk) - 3 mm (intermediate risk) expansion plus proximal 1/3 of seminal vesicles. The PTV was equal to CTV. The rectum, bladder and urethra are contoured as organs at risk. The dosimetry plan objectives are the following: prostate D90 - above 104% and V100% - above 92%; urethra D10 \< 110% , rectum D2cc\<75% (below 75Gy EQD2).

Radiation: High dose rate brachytherapy

Stereotactic ablative radiotherapy

EXPERIMENTAL

Before SBRT three fiducial markers are obligatory inserted into the prostate.Planning MRI on diagnostic table with subsequent fusing with simulation CT is obligatory. CTV to planning target volume (PTV) expansion was 3-5 mm in all direction except posteriorly (in the direction of the rectum) where it is 1-3 mm. Dose must be delivered as 5 fraction of 7.25Gy. V100% for PTV ≥ 95%. Main dose constraints are as follows: D 2cm³ ≤ 36Gy for rectum (below 75Gy EQD2)., V 37.5 Gy \<5 cm³ for bladder, V 20 Gy \<10 cm³ for femoral heads. Androgen deprivation therapy is not permitted. All treatments must be performed on conventional linear accelerators with cone beam CT guidance before each fraction, intrafractional motion monitoring is optional.

Radiation: Stereotactic ablative radiotherapy

Interventions

Stereotactic ablative radiotherapy RADIATION

Patients were randomly assigned (1:1) to conventionally high dose rate brachytherapy or stereotactic body radiotherapy. Randomisation was done Chief researcher blinded to patient data by telephone stratification by risk group (low or intermediate).

Stereotactic ablative radiotherapy

High dose rate brachytherapy RADIATION

Patients were randomly assigned (1:1) to conventionally high dose rate brachytherapy or stereotactic body radiotherapy. Randomisation was done Chief researcher blinded to patient data by telephone stratification by risk group (low or intermediate).

High dose rate brachytherapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Prostate cancer can be detected only in male patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• WHO performance status of 0-2,
• histologically confirmed prostate adenocarcinoma: Gleason score - 6-7 (4+3), clinical stage T1c-T2c, N0, M0
• T and N stage determined by clinical examinations, MRI and/or PET-CT with PSMA
• PSA below 20 ng/ml within the last 30 days
• international prostate index score (IPSS) below 16
• medically fit to spinal anesthesia
• prostate volume below 110 cm³
• maximal urinary rate above 9 ml/sec, residual urine volume below 30ml,
• in the case of previous transurethral resection interval of at least 9 months after procedure.

You may not qualify if:

• stage T3-T4,
• PSA \> 20 ng/ml,
• clinically detected lymph node or distant metastases,
• previous pelvic irradiation,
• rectal surgery.

Sponsors & Collaborators

• N.N. Petrov National Medical Research Center of Oncology: lead

Study Sites (1)

Sergey Novikov

Saint Petersburg, 197758, Russia

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific secretary

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: May 3, 2021
• Study Start: April 1, 2018
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2025
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

RU (1)