Prostate CancerPRORADNCT05645237
HRQOL in Prostate Cancer Patients Treated With Radiotherapy
An observational study of Prostate Cancer, run by Erasmus Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Apr 2019to 1 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radiotherapy, Erasmus MC Cancer Center
Rotterdam, South Holland, 3015 GD
About this study
Official title: Health-Related Quality of Life in Prostate Cancer Patients Treated With Radiotherapy
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.
Read the 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.
Study patient recruitment period was from April 2019 to May 2025, enrolling about 695 eligible patients, mainly treated with UHF 7x6.1 Gy (n=240), MHF 20x3/3.1 Gy (n=210), PORT (n=85), and brachytherapy (n=65).
- Conditions
- Prostate Cancer
- Being tested
- radiotherapy
- Keywords
- prostate cancer, radiotherapy, hypofractionation, health-related quality of life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
Radiotherapy is delivered with linear accelerators or cyberknife (external beam radiotherapy), or local irradiation with high dose rate brachytherapy (brachytherapy)
| Study group | Role | What they receive |
|---|---|---|
| Applied radiotherapy protocol (subcohort) 1 | 60 Gy in 20 fractions of 3 Gy external beam radiotherapy Receives: Radiation: radiotherapy | |
| Applied radiotherapy protocol (subcohort) 2 | 42.7 Gy in 7 fractions of 6.1 Gy external beam radiotherapy Receives: Radiation: radiotherapy | |
| Applied radiotherapy protocol (subcohort) 3 | 38 Gy in 4 fractions of 9 Gy stereotactic external beam radiotherapy Receives: Radiation: radiotherapy | |
| Applied radiotherapy protocol (subcohort) 4 | 27 Gy in 2 fractions of 13.5 Gy brachytherapy Receives: Radiation: radiotherapy | |
| Applied radiotherapy protocol (subcohort) 5 | 72 Gy in 36 fractions of 2 Gy postoperative external beam radiotherapy Receives: Radiation: radiotherapy | |
| Applied radiotherapy protocol (subcohort) 6 | 70 Gy in 35 fractions of 2 Gy on prostate combined with 52 Gy in 28 fractions of 2 Gy on pelvic lymph node areas, external beam radiotherapy. Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year 1 - Year 4
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.
Measured: Year 1 - Year 4
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
Measured: Year 1- Year 4
Secondary outcomes (7)
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.
Measured: During radiotherapy - 3 months after radiotherapy
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.
Measured: During radiotherapy - 3 months after radiotherapy
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.
Measured: Year 1 - Year 4
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.
Measured: Year 1 - Year 4
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.
Measured: Year 1 - Year 4
Late frequent bowel movements
Score of 'more than five' daily bowel movements on the Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain.
Measured: Year 1 - Year 4
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.
Measured: Year 1- Year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start8 Apr 2019
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Principal investigator, Wilma Heemsbergen, Erasmus Medical Center
- Investigators
- Luca Incrocci, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645237
- Sponsor's protocol ID
- MEC-2018-1711
- Other IDs
- project nr 14259 (HYPROSTAR)
- Acronym
- PRORAD
- Status last verified
- Aug 2025
- First submitted
- 28 Nov 2022
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Datasets used for publications (in the future) will be made available upon request. Requests for taking part in meta-analyses initiated by other research groups will be considered after publication of the main endpoints.
Publications
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.
PubMed 11113727Utomo 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.
PubMed 26453539
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life in Prostate Cancer Patients Treated With Radiotherapy
- ClinicalTrials.gov ID
- NCT05645237
- Acronym / sponsor ID
- PRORAD / MEC-2018-1711
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, radiotherapy, hypofractionation, health-related quality of life
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study patient recruitment period was from April 2019 to May 2025, enrolling about 695 eligible patients, mainly treated with UHF 7x6.1 Gy (n=240), MHF 20x3/3.1 Gy (n=210), PORT (n=85), and brachytherapy (n=65).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Applied radiotherapy protocol (subcohort) 1 | – | Radiation: radiotherapy60 Gy in 20 fractions of 3 Gy external beam radiotherapy |
| Applied radiotherapy protocol (subcohort) 2 | – | Radiation: radiotherapy42.7 Gy in 7 fractions of 6.1 Gy external beam radiotherapy |
| Applied radiotherapy protocol (subcohort) 3 | – | Radiation: radiotherapy38 Gy in 4 fractions of 9 Gy stereotactic external beam radiotherapy |
| Applied radiotherapy protocol (subcohort) 4 | – | Radiation: radiotherapy27 Gy in 2 fractions of 13.5 Gy brachytherapy |
| Applied radiotherapy protocol (subcohort) 5 | – | Radiation: radiotherapy72 Gy in 36 fractions of 2 Gy postoperative external beam radiotherapy |
| Applied radiotherapy protocol (subcohort) 6 | – | Radiation: radiotherapy70 Gy in 35 fractions of 2 Gy on prostate combined with 52 Gy in 28 fractions of 2 Gy on pelvic lymph node areas, external beam radiotherapy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapyRadiotherapy is delivered with linear accelerators or cyberknife (external beam radiotherapy), or local irradiation with high dose rate brachytherapy (brachytherapy) | Radiation | Applied radiotherapy protocol (subcohort) 1, Applied radiotherapy protocol (subcohort) 2, Applied radiotherapy protocol (subcohort) 3, Applied radiotherapy protocol (subcohort) 4, Applied radiotherapy protocol (subcohort) 5, Applied radiotherapy protocol (subcohort) 6 |
Primary outcome
EPIC questionnaire score on urinary domain
Time frame: Year 1 - Year 4
Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain score: a 0 to 100 scale with higher scores representing better HRQOL.
EPIC questionnaire score on bowel domain
Time frame: Year 1 - Year 4
Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain score: a 0 to 100 scale with higher scores representing better HRQOL.
Sexual functioning score on IIEF-5 questionnaire
Time frame: Year 1- Year 4
Sexual functioning score on International Index of Erectile Function (IIEF-5) questionnaire: 1 to 25 scale, higher scores imply better function
7 secondary outcomes
Acute rectal bleeding, on symptom checklist (patient-reported)
Time frame: During radiotherapy - 3 months after radiotherapy
Acute mucous discharge, on symptom checklist (patient-reported)
Time frame: During radiotherapy - 3 months after radiotherapy
Late moderate to severe urinary incontinence
Time frame: Year 1 - Year 4
Late moderate to severe urinary frequency during the night
Time frame: Year 1 - Year 4
Late moderate to severe incontinence for stools
Time frame: Year 1 - Year 4
Late frequent bowel movements
Time frame: Year 1 - Year 4
Late erectile dysfunction
Time frame: Year 1- Year 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 11113727Wei 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.
- Background: PubMed 26453539Utomo 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.
- Protocol Registration Quality Control Review Criteria of ClinicalTrials.govLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Datasets used for publications (in the future) will be made available upon request. Requests for taking part in meta-analyses initiated by other research groups will be considered after publication of the main endpoints.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Incrocci, MD PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EPIC questionnaire score on urinary domain (time frame: Year 1 - Year 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05645237, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.