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Trial Title:
HRQOL in Prostate Cancer Patients Treated With Radiotherapy
NCT ID:
NCT05645237
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
prostate cancer
radiotherapy
hypofractionation
health-related quality of life
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
radiotherapy
Description:
Radiotherapy is delivered with linear accelerators or cyberknife (external beam
radiotherapy), or local irradiation with high dose rate brachytherapy (brachytherapy)
Arm group label:
Applied radiotherapy protocol (subcohort) 1
Arm group label:
Applied radiotherapy protocol (subcohort) 2
Arm group label:
Applied radiotherapy protocol (subcohort) 3
Arm group label:
Applied radiotherapy protocol (subcohort) 4
Arm group label:
Applied radiotherapy protocol (subcohort) 5
Arm group label:
Applied radiotherapy protocol (subcohort) 6
Summary:
The study primarily aims at evaluating health-related quality of life after radiotherapy
for prostate cancer, using modern hypofractionated radiotherapy schedules. Study design
is a prospective observational cohort study. All patients give written informed consent
and fill out online validated questionnaires before, during, and after radiotherapy
(yearly) up to 5 years post-treatment.
Detailed description:
Rationale: Patient-Reported Outcomes (PROs), such as health-related quality of life
(HRQL), have achieved an important role in the evaluation of benefits and harms after
cancer treatment, including radiotherapy for prostate cancer (PCa). In the past year,
clinical radiotherapy protocols at the Erasmus MC have been changed for external beam
radiotherapy (EBRT) as well as for brachytherapy (BT). In order to evaluate the current,
changed, clinical practice, we will conduct a prospective cohort study, with the main
purpose to assess HRQL for the current treatment options at the Erasmus MC.
Objective: To establish HRQL (start treatment - 5 years after treatment) in a prospective
cohort of ≈600 patients with localized PCa treated with radiotherapy within in the period
≈ 1/3/2019 - 1/12/2023.
Main objective: to establish changes in HRQL levels (with respect to baseline) up to 5
year post-treatment, within each radiotherapy modality for prostate cancer patients, i.e.
EBRT 60 Gy in 20 fractions, EBRT 42.7 Gy in 7 fractions, CyberKnife (stereotactic EBRT)
38 Gy in 4 fractions, BT 27 Gy in 2 fractions, postoperative EBRT (PORT) 72 Gy in 36
fractions, EBRT for LN+: 70 Gy (prostate)/52 Gy (lymph nodes) in 28 fractions.
Study design: Prospective observational cohort study. Study population: Patients with
prostate cancer T1c-T4 referred for radiotherapy at the Erasmus MC as a primary treatment
with curative intent or as first line adjuvant treatment after a prostatectomy.
Intervention: All interventions are according to applicable standard clinical procedures
& protocols for localized prostate cancer of the Radiotherapy department.
Main study parameters/endpoints: HRQL scores of the EPIC (urinary domain, bowel domain),
and the IIEF-5 (sexual function) score.
Nature and extent of the burden and risks associated with participation, benefit and
group relatedness: There are no additional risks or benefits for patients that
participate in the study. The additional burden is to fill out questionnaires at regular
intervals.
Criteria for eligibility:
Study pop:
Clinically T1c-T4, N0 (or N+ in case of EBRT-LN+), M0 prostate cancer patients referred
for radiotherapy to the Erasmus Medical Center.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Clinically T1c-T4, N0 (or N+ in case of EBRT-LN+), M0 prostate cancer patient
referred for radiotherapy.
- Willing and capable to fill out Dutch questionnaires on health-related items at a
computer (online questionnaires).
- Signed written Informed Consent.
Exclusion Criteria:
- Previously radiation treatment in the pelvic region, for any reason.
- Diagnosed with other tumor in the past 12 months or known with tumor progression of
another tumor.
- Postoperative radiotherapy with dose levels < 72 Gy.
Gender:
Male
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Radiotherapy, Erasmus MC Cancer Center
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Wilma Heemsbergen
Phone:
+31650033202
Email:
w.heemsbergen@erasmusmc.nl
Contact backup:
Last name:
Kim de Vries
Phone:
+31107041421
Email:
k.devries@erasmusmc.nl
Investigator:
Last name:
Luca Incrocci, MD PhD
Email:
Principal Investigator
Investigator:
Last name:
Kim de Vries, MD
Email:
Sub-Investigator
Investigator:
Last name:
Miranda Christianen, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Martine Franckena, MD PhD
Email:
Sub-Investigator
Start date:
April 8, 2019
Completion date:
January 1, 2028
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
Dutch Cancer Society
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05645237
https://prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf
