HRQOL in Prostate Cancer Patients Treated With Radiotherapy

Prostate Cancer Clinical Trial

— PRORAD  

Official title:

Health-Related Quality of Life in Prostate Cancer Patients Treated With Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645237
• Other study ID #: MEC-2018-1711
• Secondary ID: project nr 14259
• Status: Recruiting
• Start date: April 8, 2019
• Est. completion date: January 1, 2028

Study information

• Verified date: December 2022
• Source: Erasmus Medical Center
• Contact: Wilma Heemsbergen, PhD
• Phone: +31650033202
• Email: w.heemsbergen[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• radiotherapy
Radiotherapy is delivered with linear accelerators or cyberknife (external beam radiotherapy), or local irradiation with high dose rate brachytherapy (brachytherapy)

Locations

Country	Name	City	State
Netherlands	Radiotherapy, Erasmus MC Cancer Center	Rotterdam	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General health score on EQ-5D-5L questionnaire	General health score on EuroQoL 5-dimensions, 5-levels (EQ-5D-5L) questionnaire: total score between -1 - +1,higher score indicates better quality of life.	Year 1- Year 4
Other	Acute moderate to severe rectal discomfort	Score of 'quite/a lot' for the symptom 'pain with stools' and/or 'cramping urge',	During radiotherapy - 3 months after radiotherapy
Other	Late watery bowel movements	Score of 'moderate/big problem for watery bowel movements' on the Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain.	Year 1 - Year 4
Other	Late gastrointestinal pain	Score of 'moderate/big problem for abdominal/pelvic/rectal pain' on the Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain.	Year 1 - Year 4
Primary	EPIC questionnaire score on urinary domain	Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain score: a 0 to 100 scale with higher scores representing better HRQOL.	Year 1 - Year 4
Primary	EPIC questionnaire score on bowel domain	Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain score: a 0 to 100 scale with higher scores representing better HRQOL.	Year 1 - Year 4
Primary	Sexual functioning score on IIEF-5 questionnaire	Sexual functioning score on International Index of Erectile Function (IIEF-5) questionnaire: 1 to 25 scale, higher scores imply better function	Year 1- Year 4
Secondary	Acute rectal bleeding, on symptom checklist (patient-reported)	Rectal bleeding is scored on a symptom checklist on a Likert scale (bother: none, little, quite, a lot) (patient-reported), higher score means worse symptoms. This symptom checklist was locally developed and used in previous trials.	During radiotherapy - 3 months after radiotherapy
Secondary	Acute mucous discharge, on symptom checklist (patient-reported)	Mucous discharge is scored on a symptom checklist on a Likert scale (bother: none, little, quite, a lot) (patient-reported), higher score means worse symptoms. This symptom checklist was locally developed and used in previous trials.	During radiotherapy - 3 months after radiotherapy
Secondary	Late moderate to severe urinary incontinence	Score of 'more than once a week or daily leaking of urine' on the Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain.	Year 1 - Year 4
Secondary	Late moderate to severe urinary frequency during the night	Score of 'moderate/big problem for waking up to urinate' on the Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain.	Year 1 - Year 4
Secondary	Late moderate to severe incontinence for stools	Score of 'more than once a week or daily uncontrolled leakage of stools/feces' on the Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain.	Year 1 - Year 4
Secondary	Late frequent bowel movements	Score of 'more than five' daily bowel movements on the Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain.	Year 1 - Year 4
Secondary	Late erectile dysfunction	Score of 'very low/low confidence to get and keep an erection' on the International Index of Erectile Function (IIEF-5) questionnaire.	Year 1- Year 4

External Links

•   Protocol Registration Quality Control Review Criteria of ClinicalTrials.gov