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

Adenocarcinoma of Prostate Clinical Trial

— PROMOBRA  

Official title:

Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02258087
• Other study ID #: PROMOBRA-2013
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 30, 2014
• Last updated: October 2, 2014
• Start date: September 2014
• Est. completion date: September 2019

Study information

• Verified date: October 2014
• Source: National Institute of Oncology, Hungary
• Contact: Peter Agoston, MD PHD
• Phone: +361 2248600
• Email: agoston.p[@]oncol.hu
• Is FDA regulated: No
• Health authority: Hungary: Research Ethics Medical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Prostate
• Prostatic Neoplasms

Intervention

Radiation:
• LDR Brachytherapy
In spinal anaesthesia patients' prostate are treated with low-dose-rate or brachytherapy using transrectal ultrasound guidance. Radiation sources (iodine-125 isotopes) are implanted into the prostate through transperineal needle insertion. Real time dose planning is applied. The prescribed dose to the whole prostate is 145 Gy.
• HDR Brachytherapy
In spinal anaesthesia patients' prostate are treated with one fraction of HDR brachytherapy. The prescribed dose to the whole prostate is 1x19 Gy. Ir-192 radioactive stepping source is used for the treatment with after-loading technique. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time intraoperative needle position update and dose optimization is applied.

Locations

Country	Name	City	State
Hungary	Peter Agoston	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Oncology, Hungary

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute side effects	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	6 months	Yes
Primary	Chronic side effects	Chronic gastrointestinal, urogenital and other side effects occuring within six months after the procedure, according to the CTCAE 4.0v scale	from 6 months to five year	Yes
Secondary	quality of life	Assessing patients' quality of life according to the a 25 question prostate module (PR-25) of the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QlQ-30).	5 years	Yes
Secondary	quality of life	Assessing patients' quality of life according to the International Index for Erectile Function (IIEF) questionnaire	5 years	Yes
Secondary	Biochemical relapse free survival (bRFS)	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)	5 years	Yes
Secondary	Locoregional tumor free survival	Censoring an event when either local or regional relapse occurs	5 years	Yes
Secondary	Disease specific survival (DSS)	Censoring an event when patient dies due to prostate cancer	5 years	Yes