Clinical trial NCT05645237: HRQOL in Prostate Cancer Patients Treated With Radiotherapy
Official title: Health-Related Quality of Life in Prostate Cancer Patients Treated With Radiotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: prostate cancer
radiotherapy
hypofractionation
health-related quality of life
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2022-12-09
Enrollment: 600
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinically T1c-T4, N0 (or N+ in case of EBRT-LN+), M0 prostate cancer patients referred for radiotherapy to the Erasmus Medical Center.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: EPIC questionnaire score on urinary domain
timeFrame: Year 1 - Year 4
measure: EPIC questionnaire score on bowel domain
timeFrame: Year 1 - Year 4
measure: Sexual functioning score on IIEF-5 questionnaire
timeFrame: Year 1- Year 4
Secondary outcomes:
measure: Acute rectal bleeding, on symptom checklist (patient-reported)
timeFrame: During radiotherapy - 3 months after radiotherapy
measure: Acute mucous discharge, on symptom checklist (patient-reported)
timeFrame: During radiotherapy - 3 months after radiotherapy
measure: Late moderate to severe urinary incontinence
timeFrame: Year 1 - Year 4
measure: Late moderate to severe urinary frequency during the night
timeFrame: Year 1 - Year 4
measure: Late moderate to severe incontinence for stools
timeFrame: Year 1 - Year 4
measure: Late frequent bowel movements
timeFrame: Year 1 - Year 4
measure: Late erectile dysfunction
timeFrame: Year 1- Year 4
Other outcomes:
measure: General health score on EQ-5D-5L questionnaire
timeFrame: Year 1- Year 4
measure: Acute moderate to severe rectal discomfort
timeFrame: During radiotherapy - 3 months after radiotherapy
measure: Late watery bowel movements
timeFrame: Year 1 - Year 4
measure: Late gastrointestinal pain
timeFrame: Year 1 - Year 4
Locations:
city: Rotterdam
country: Netherlands
facility: Radiotherapy, Erasmus MC Cancer Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Luca Incrocci, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000 Dec 20;56(6):899-905. doi: 10.1016/s0090-4295(00)00858-x.
citation: Utomo E, Blok BF, Pastoor H, Bangma CH, Korfage IJ. The measurement properties of the five-item International Index of Erectile Function (IIEF-5): a Dutch validation study. Andrology. 2015 Nov;3(6):1154-9. doi: 10.1111/andr.12112. Epub 2015 Oct 9.