HDR vs LDR Brachytherapy as Monotherapy in the Treatment of Localized Prostate Cancer.

Phase 2

• Conditions: Adenocarcinoma of Prostate
• Interventions: Radiation: LDR Brachytherapy; Radiation: HDR Brachytherapy

• Registration Number: NCT02258087
• Lead Sponsor: National Institute of Oncology, Hungary

Brief Summary

Investigators compare in a randomized clinical trial the results and side effects of high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ confined prostate cancer patients.

Detailed Description

Permanent implant prostate brachytherapy (LDRPBT) is a well established and proved method in the treatment of patients with low or selected intermediate risk, organ confined prostate cancer.

There are number of studies with high-dose rate brachytherapy (HDRPBT) as monotherapy with several fractionation schedule treating the same group of patients. One phase II trial showed its effectiveness given in one fraction of 19 Gy.

In the trial investigators randomly select patients to treat with either LDR prostate brachytherapy (145Gy) or HDR prostate brachytherapy (1x19Gy) as monotherapy.

Patients are stratified into two pretreatment group: 1. low risk, 2. selected intermediate risk group.

Brachytherapy is given in spinal anaesthesia, using transrectal ultrasound based real time treatment planning. Dose constraints are defined for both methods.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-30
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-02
• Last Update Submitted: 2014-10-02
• Study First Posted: 2014-10-07
• Last Update Posted: 2014-10-07
• Primary Completion: 2017-09
• Study Completion: 2019-09

Recruitment & Eligibility

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

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) status <=1
• 40-75 years old
• expected life expectancy>10 years
• low risk prostate cancer (Prostate specific antigen (PSA)<=10ng/ml, gleason score <7, T status<=2a), less than 50 % positive biopsy cores
• selected intermediate prostate cancer (PSA)=10-<15ng/ml or gleason score =3+4(but not 4+3), or T2b-c, less than 50 % positive biopsy cores)
• International prostate symptom score (IPSS) <=15
• Prostate volume<=50cm3
• no pubic interference
• no prior prostate operation, except biopsy
• no prior radiation to pelvis
• patient signed the informed consent

Exclusion Criteria

• <40 years or >75 years old
• PSA>15 ng/ml gleason score 4+3 , score 8-10
• ECOG>=2
• T3-4
• percent core positivity >50 %
• TUR operation within six months prior to the brachytherapy prostate volume<10 cm3 or >50 cm3 IPSS >15

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDRPBT	LDR Brachytherapy	Patients with low and selected intermediate risk prostate cancer are treated with Prostate LDR brachytherapy as monotherapy. 145 Gy is prescribed to the prostate. I-125 radioactive sources are used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.
HDRPBT	HDR Brachytherapy	Patients with low and selected intermediate risk prostate cancer are treated with prostate HDR brachytherapy as monotherapy. The prescribed dose is 1x19 Gy to the whole prostate. Ir-192 radioactive source is used. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time dose optimization is applied.

Primary Outcome Measures

Name	Time	Method
Acute side effects	6 months	Acute gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the Common Toxicity Criteria for Adverse Effects (CTCAE 4.0v) scale
Chronic side effects	from 6 months to five year	Chronic gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the CTCAE 4.0v scale

Secondary Outcome Measures

Name	Time	Method
Disease specific survival (DSS)	5 years	Censoring an event when patient dies due to prostate cancer
quality of life	5 years	Assessing patients' quality of life according to the International Index for Erectile Function (IIEF) questionnaire
Locoregional tumor free survival	5 years	Censoring an event when either local or regional relapse occurs
Biochemical relapse free survival (bRFS)	5 years	Censoring an event when biochemical relapse occurs using the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition for PSA relapse (nadir + 2 ng/ml increase)

Trial Locations

Locations (1)

Peter Agoston; 🇭🇺 Budapest, Hungary