The main objective is to assess if partial prostate brachytherapy will lead to less erectile dysfunction than whole gland prostate brachytherapy.Secondary objectives are:- To assess differences in urinary and rectal late effects between whole gland…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is deterioration of erectile function by assessment of the
IIEF-5 score. A drop of at least 5 points compared to baseline
value or a need to start with a phosphodiesterase 5 inhibitor (PDE5 inhibitor)
(or other medical interventions to improve erections) at last follow-up is
considered as an event.
Secondary outcome
Secondary objectives are:
- To assess differences in urinary and rectal late effects between whole gland
and partial prostate brachytherapy.
- To assess differences in post-procedural quality of life measured by EORTC
QLQC30 and QLQ-PR25 questionnaire.
- To assess the local oncological efficacy as measured by the proportion of men
who are free of local prostate cancer in the two different groups. This will be
examined by standardized 12 core prostate biopsies and mpMRI.
Background summary
A drawback of the standard whole gland brachytherapy for prostate cancer is
that large volumes of sensitive organs and structures are irradiated to a high
dose. The unavoidable dose on these organs and structures will lead to unwanted
late effects. Reducing the irradiated volume for a selected group of patients
with unilateral low-risk significant disease can reduce the probability of late
effects. The hypothesis in this study is that by performing hemigland
brachytherapy the incidence of erectile dysfunction can be reduced by 20%.
Study objective
The main objective is to assess if partial prostate brachytherapy will lead to
less erectile dysfunction than whole gland prostate brachytherapy.
Secondary objectives are:
- To assess differences in urinary and rectal late effects between whole gland
and partial prostate brachytherapy.
- To assess differences in post-procedural quality of life measured by EORTC
QLQC30 and QLQ-PR25 questionnaire.
- To assess the local oncological efficacy as measured by the proportion of men
who are free of local prostate cancer in the two different groups. This will be
examined by standardized 12 core prostate biopsies and mpMRI.
Study design
This study is designed as a randomized study between whole gland prostate
brachytherapy (control arm) and hemigland prostate brachytherapy (experimental
arm).
Intervention
All patients are treated with brachytherapy either on the whole gland or
hemigland. The treatments are performed with a permanent implantation with
I-125 sources or a temporary implantation with HDR.
Study burden and risks
The treatment burden will not be much different than what is common for the
standard whole gland brachytherapy. After the regular diagnostics patients will
be treated either on a same admission-day policy or a short hospitalisation.
That will not be different between the two study arms. To be eligible for this
study extra investigations will be performed, such as template prostate
biopsies and mpMRI, which is not standard practice
everywhere. In the follow-up, late effect and quality of life forms need to be
filled in by the patients and standard 12 core prostate biopsies and mpMRI will
be performed. When only a part of the prostate is treated there is evidently a
risk to undertreat and jeopardize the patient*s life.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1. Histologically adenocarcinoma on systematic prostate biopsies and targeted
biopsies after mpMRI
2. Unilateral tumor confirmed by histology.
3. Clinical stage T1c-T2b
4. Gleason score 3 + 3 with >=30% tumor of all taken cores (ISUP Grade Group 1),
Gleason score 3 + 4 (ISUP Grade Group 2), and Gleason 4 + 3 (ISUP Grade Group
3)
5. PSA <=15 ng/ml and Gleason 7 (Grade Group 2-3) or PSA <=20 ng/mL and Gleason 6
(Grade Group 1)
6. Baseline IIEF-5 score >=12
7. Sexually active
8. International Prostate Symptom Score (IPSS) <= 20
9. WHO performance score <= 2
10. Age > 18 years
11. Written informed consent
Exclusion criteria
1. Contraindication for mpMRI
2. Bleeding disorder preventing invasive treatment as a prostate implantation
3. Not able to stop coumarine derivates
4. Active urinary tract infection
5. Any history of bladder neck stricture
6. Comorbidity preventing general or spinal anesthesia
7. Any history of inflammatory bowel disease
8. Prior or concurrent malignancy except for non-melanoma skin cancer or other
malignancy from which the patient has been cured for at least 5 years
9. Life expectancy of < 5 years
10. Prostate calcifications greater than 5 mm
11. Chemotherapy for prostate cancer
12. Hormonal therapy for prostate cancer within 1 year prior to procedure
13. Previous radiation to pelvis
14. Recurrent prostate cancer
15. Transurethral resection of the prostate or urethral stent
16. Prior major rectal surgery (except haemorrhoids)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL62771.018.17 |
| Other | NL7073/ NTR7271 |
| OMON | NL-OMON26328 |