Effectiveness of Three Primary Treatments for Localized Prostate Cancer: Radical Prostatectomy, External-beam Radiotherapy, and Prostate Brachytherapy

Effectiveness of Localized Prostate Cancer Treatments

Sponsors

Lead sponsor: Fundacion IMIM

Source Fundacion IMIM
Brief Summary

The purpose of this study is to evaluate the effectiveness of the three most established primary treatments for patients with clinically localized prostate cancer (radical prostatectomy, external-beam radiotherapy, and prostate brachytherapy) at short, mid and long-term follow-up. The primary aim is assessing Quality of Life impact of treatments' side effects. As secondary objectives biochemical disease-free survival, overall survival, and prostate cancer-specific survival will be also assessed.

Detailed Description

Primary Objective:

To assess the Quality of Life impact of treatments' side effects (radical prostatectomy, external beam radiotherapy and prostate brachytherapy) on patients with localized prostate cancer at short, mid and long-term follow-up.

Secondary Objectives:

- To assess biochemical disease-free survival by treatment and risk group, at mid and long-term follow-up.

- To assess overall survival by treatment and risk group, at mid and long-term follow-up.

- To assess prostate cancer-specific survival by treatment and risk group, at long-term follow-up.

- To assess disease-free survival by treatment and risk group, at long-term follow-up.

- To assess perceived general health and cancer-specific quality of life by treatment and risk group, at short, mid and long-term follow-up.

- To calculate the resource use and cost of the three primary treatments.

- To assess preferences with direct and indirect methods.

Outline:

This is a prospective observational study of a cohort with clinically localized prostate cancer treated with either radical retropubic prostatectomy, three-dimensional external-beam radiotherapy, or interstitial brachytherapy.

Participants are consecutively recruited in 10 Spanish hospital departments (located in five autonomous communities). Patients eligible for inclusion were those in stage T1 or T2, treated in one of the participating centers and without previous prostate transurethral resection. Patients are staged according to the 1992 American Joint Committee on Cancer clinical staging guidelines using a directed history and physical examination. The decision regarding treatment is made jointly by patients and health professionals.

Demographic and clinical characteristics at baseline are recorded at clinical sites and include age, Prostate Specific Antigen (PSA), Gleason grading, prostate volume, risk group and use of neoadjuvant hormonal treatment. According tho the national health guidelines participants are visited every 6-12 months after treatment.

Quality of Life questionnaires are administered centrally by telephone interview before treatment and during follow-up at 1, 3, 6, and 12 months after treatment the first year, then annually until 10 years, and every 5 years thereafter. Quality of Life evaluations are gathered using computer-assisted telephone administration and include: (1) the Expanded Prostate Cancer Index Composite (EPIC), specifically designed to measure the impact of the different treatments; (2) SF-36 Health Survey Questionnaire; (3) Functional Assessment of cancer Therapy, General and Prostate specific (FACT-G and FACT-P, respectively); (4) International Prostate Symptom Score (IPSS); and (5) International Index of Erectile Function (IIES).

A total of 120 patients was calculated to be required in each treatment group to detect between-treatment group differences of 5-points on the urinary irritative-obstructive score of the EPIC questionnaire given a standard deviation of 18.99 and a statistical power of at least 80% at a significance level of 5%, with an expected loss to follow-up of 10%. The analyst is blinded to treatment assignation.

Overall Status Active, not recruiting
Start Date April 2003
Completion Date December 2025
Primary Completion Date May 2015
Study Type Observational
Primary Outcome
Measure Time Frame
Quality of Life impact of treatments' side effects measured by change in the Expanded Prostate Cancer Index Composite (EPIC) score from baseline to 2, 5, 7 and 10 years after treatment and every 5 years thereafter. 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
Secondary Outcome
Measure Time Frame
Biochemical disease-free survival 5, 7 and 10 years after treatment and every 5 years thereafter.
Overall survival 5, 7 and 10 years after treatment and every 5 years thereafter.
Prostate cancer-specific survival 10 years after treatment and then every 5 years thereafter.
Disease-Free Survival 10 years after treatment and every 5 years thereafter.
Perceived general health measured by the Medical Outcomes Study 36-Item Short Form (SF-36). 2, 5, 7 and 10 years after treatment and then every 5 years thereafter.
Cancer specific Quality of Life measured by the Functional Assessment of Cancer Therapy - General and Prostate specific - (FACT-G and FACT-P, respectively). 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
Urinary symptoms measured by the International Prostate Symptom Score (IPSS). 2, 5, 7 and 10 years after treatment and every 5 years thereafter.
Sexual symptoms measured by the International Index of Erectile Function (IIES). 2, 5, 7 and 10 years after treatment and then every 5 years thereafter.
Resource use as assessed by routine hospital and primary care data source with additional questions in clinical and participants questionnaires. 5, 7 and 10 years after treatment and every 5 years thereafter.
Utilities measured by the Short Form-6D (SF-6D), a subset of the SF-36, and additional questions to estimate preferences by time-trade off, standard gamble and willingness to pay. 5, 7 and 10 years after treatment and every 5 years thereafter.
Enrollment 500
Condition
Intervention

Intervention type: Behavioral

Intervention name: Quality of life assessment and Clinical evaluation

Description: quality of life assessed by the Expanded Prostate Cancer Index Composite (EPIC), the Medical Outcomes Study 36-Item Short Form (SF-36) version 2, the Functional Assessment of cancer Therapy, General and Prostate specific (FACT-G and FACT-P, respectively), the International Prostate Symptom Score (IPSS), and the International Index of Erectile Function (IIES). Quality of Life questionnaires are administered centrally by telephone interview before treatment and during follow-up at 1, 3, 6, and 12 months after treatment the first year, then annually until 10 years, and every 5 years thereafter. Demographic and clinical characteristics at baseline are recorded at clinical sites and include age, Prostate Specific Antigen (PSA), Gleason grading, prostate volume, risk group and use of neoadjuvant hormonal treatment. According tho the national health guidelines participants are visited every 6-12 months after treatment.

Arm group label: Spanish Multicentric Clinically Localized Prostate Cancer

Intervention type: Procedure

Intervention name: Radical retropubic prostatectomy surgery

Description: The surgery group underwent radical retropubic prostatectomy. The surgery is performed by a technique based on a modification of the radical retropubic prostatectomy described by Walsh. The prostatectomy is performed in retrograde way, preserving the neurovascular bundles if feasible, controlling the vessels with titanium clips, and avoiding any kind of coagulation to decrease the risk of neurovascular bundle damage. The bladder neck may be preserved on surgeon criteria. Lymph node dissection is rarely performed due to the extremely low risk of metastatic involvement in this subset of patients. The operative time is about 2 to 3 hours and required hospital stay. The patient has a urinary catheter placed for 1 to 3 weeks to facilitate bladder emptying.

Arm group label: Spanish Multicentric Clinically Localized Prostate Cancer

Intervention type: Radiation

Intervention name: External beam radiotherapy

Description: External beam radiation is carried out with the 3D conformal technique. Patients are treated in a supine position by immobilizing feet and legs. Data from a computed tomography (CT) scan performed with the patient in the treatment position were entered into a 3D treatment-planning system to outline prostate, bladder, and rectum on each slice. Seminal vesicles and regional lymphatics are also contoured if a high risk of involvement was suspected. Applied margins are used to calculate prostate planning target volume (PTV). Custom blocking with Cerrobend blocks or multileaf collimators are designed using beam's eye view, and additional margins were adjusted to provide a minimum dose of 95% to the prostate PTV. Treatment is delivered in 1.8 to 2.0 Gy daily fractions, 5 days per week. Off-line setup control is assessed weekly by comparing orthogonal portal images with the corresponding digitally reconstructed radiographs.

Arm group label: Spanish Multicentric Clinically Localized Prostate Cancer

Intervention type: Radiation

Intervention name: Prostate Brachytherapy

Description: Brachytherapy is performed by pre-planned procedure. Under epidural anaesthesia, the patient is placed in the lithotomy position (forced lithotomy position larger prostate volumes) and, after probing the patient, the best prostate spatial location is searched, proceeding then to prepare the sterile field and bladder catheterization. A prostate volumetry with a three-dimensional reconstruction is performed and automatically transferred to the scheduler, which processes the images and outlines the prostate, urethra and rectum in each of the sections. In LDR prostate brachytherapy, the prostate gland corresponds to the PTV. The standard dose for 100% isodose is 145 Gy according to the TG-T43 for I-125 sources. Dosimetry calculation of the automatically prescribed dosage is then estimated, with a final manual optimization.

Arm group label: Spanish Multicentric Clinically Localized Prostate Cancer

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Stage T1 or T2, treated with radical retropubic prostatectomy, external beam radiotherapy, or interstitial brachytherapy

Exclusion Criteria:

- Previous prostate transurethral resection

- Treated in other hospitals out of the participating centers

Gender: Male

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Montserrat Ferrer Fores, PhD, MD Principal Investigator Fundacio IMIM
Location
facility
Hospital Universitari de Bellvitge
Instituto Catalán de Oncología
Capio Hospital General de Cataluña
Instituto Oncológico de Gipuzkoa
Centro Oncológico de Galicia
Fundació Puigvert
Hospital de La Santa Creu I Sant Pau
Hospital Ramon Y Cajal
Hospital Regional Carlos Haya
Hospitales Universitarios Virgen Del Rocío
Location Countries

Spain

Verification Date

February 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Fundacion IMIM

Investigator full name: Montserrat Ferrer

Investigator title: MD

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Spanish Multicentric Clinically Localized Prostate Cancer

Description: A consecutive sample of clinically localized prostate cancer patients treated with radical prostatectomy, external beam radiotherapy and prostate brachytherapy in 10 Spanish hospitals.

Acronym E-PROSTCaT
Patient Data Undecided
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov