Prostate CancerRECOVERNCT05931419
High-Risk prostatE Cancer radiatiOn Versus surgERy
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by Comprehensive Cancer Centre The Netherlands at 28 sites in Netherlands.
Trial summary
Prospective cohort study comparing robot-assisted radical prostatectomy and external beam radiotherapy +/- androgen deprivation therapy for high-risk non-metastatic prostate cancer in terms of health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival and distant metastasis-free… Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- How many people
- 837 participants
- Where
- 28 sitesNetherlands
- Study dates
- 16 Feb 2023to 30 Jun 2030
- How long will I take part?
- 5 Years
- 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 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with de novo non-metastatic high-risk prostate cancer (cT3a-bN0M0 and/or ISUP grade ≥4 and/or PSA >20ng/ml), who have opted for treatment with RARP or EBRT +/- ADT and are diagnosed in, or are referred to one of the participating hospitals
Who may be able to join
- Histologically confirmed de novo non-metastatic high-risk prostate cancer.
- cT3a-bN0M0, according to the 8th edition of the Tumour, Node, Metastasis (TNM) classification, with the exception that clinical T-stage will be based on digital rectal examination and magnetic resonance imaging (the highest stage will be used) and/or
- International Society of Urological Pathology (ISUP) grade ≥4 and/or
- Prostate-Specific Antigen (PSA) value at diagnosis greater than 20 ng/mL
- Fit for treatment with either RARP or EBRT +/- ADT (WHO performance status 0-1)
- Living in the Netherlands
- Able to read and understand the Dutch language
Who cannot join
- Histological types other than adenocarcinoma
- Diagnosis and/or treatment in a hospital abroad
- Treatment with Androgen Receptor Targeted Agents (ARTA) as part of the initial treatment plan
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
Netherlands28 sites, 24 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar
- Recruiting
Amsterdam UMC
Amsterdam
- Recruiting
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam
- Recruiting
BovenIJ ziekenhuis
Amsterdam
- Recruiting
OLVG
Amsterdam
- Recruiting
Wilhelmina Ziekenhuis
Assen
- Recruiting
Rode Kruis Ziekenhuis
Beverwijk
- Recruiting
Albert Schweitzer Ziekenhuis
Dordrecht
- Completed
Catharina Ziekenhuis
Eindhoven
- Recruiting
Admiraal de Ruyter Ziekenhuis
Goes
- Recruiting
Martini ziekenhuis
Groningen
- Recruiting
Universitair Medisch Centrum Groningen
Groningen
- Recruiting
Saxenburgh Medisch Centrum
Hardenberg
- Recruiting
St Jansdal
Harderwijk
- Recruiting
Spaarne Gasthuis
Hoofddorp
- Recruiting
Treant
Hoogeveen
- Recruiting
Dijklander Ziekenhuis
Hoorn
- Recruiting
Leids Universitair Medisch Centrum
Leiden
- Completed
Canisius Wilhelmina Ziekenhuis
Nijmegen
- Completed
Radboudumc
Nijmegen
- Recruiting
Erasmus Medisch Centrum Rotterdam
Rotterdam
- Recruiting
Franciscus Gasthuis & Vlietland
Rotterdam
- Recruiting
Maasstad Ziekenhuis
Rotterdam
- Recruiting
Ommelander Ziekenhuis
Scheemda
- Recruiting
Haaglanden Medisch Centrum
The Hague
- Recruiting
Verbeeten Instituut
Tilburg
- Completed
Maxima Medisch Centrum
Veldhoven
- Recruiting
Zaans Medisch Centrum
Zaandam
About this study
Official title: High-Risk prostatE Cancer radiatiOn Versus surgERy (RECOVER)
Prospective cohort study comparing robot-assisted radical prostatectomy and external beam radiotherapy +/- androgen deprivation therapy for high-risk non-metastatic prostate cancer in terms of health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival and distant metastasis-free survival.
Read the detailed description
Detailed description: Robot assisted radical prostatectomy (RARP) and external beam radiotherapy (EBRT) often combined with Androgen Deprivation Therapy (ADT) are widely used treatment modalities for high-risk non-metastatic prostate cancer (HR-PCa). Both treatments are associated with adverse effects and can have a great impact on health-related quality of life (HRQoL). To date there is no consensus on which of both is the optimal treatment for men with HR-PCa, as it is unclear which treatment is superior in terms of HRQoL, cost-effectiveness, progression-free survival (PFS) and distant metastases-free survival (DMFS). This is reflected in substantial variation between individual hospitals in the utilization of both treatment options that is not explained by patient- and tumor characteristics or patient preferences. In the RECOVER study we aim to address this knowledge gap. The insights gained can be used to tailor recommendations in (national) guidelines and in shared decision-making tools. This allows healthcare professionals to better inform their patients and allows patients to make well-informed choices.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- Radical prostatectomy, Radiotherapy, Health-related quality of life, Functional outcomes, Progression-free survival, Distant metastases-free survival, Cost-effectiveness
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted radical prostatectomy (RARP) | Robot-assisted radical prostatectomy, potentially as part of multimodality therapy with adjuvant radiotherapy or with (neo)adjuvant androgen deprivation therapy. Pelvic lymph node dissection (PLND) may be performed for staging purposes. The presence of positive lymph nodes (pN1) upon PLND is not a reason for exclusion and may be followed by adjuvant treatment such as lymph node irradiation. | |
| External beam radiotherapy (EBRT) +/- androgen deprivation therapy (ADT) | External beam radiotherapy (hypofractionated or conventionally fractionated) at a biologically effective dose converted to 2Gy fractions (α/β:1.5) of at least 76Gy. EBRT may also be combined with a brachytherapy boost and PLND may be performed for staging purposes. The presence of positive lymph nodes (pN1) upon PLND is not a reason for exclusion and lymph node irradiation may be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcomes
Functional outcomes will be measured with the Expanded Prostate Cancer Index Composite Short Form (EPIC-26). The EPIC-26 consists of 5 domains: urinary incontinence, urinary irritation, bowel function, sexual function and hormonal function. Domain scores range from 0-100 (the higher the score the better the function) and the minimally clinically important difference (MCID) per domain is 6-9, 5-7, 4-6, 10-12 and 4-6, respectively.
Measured: 3 years after treatment initiation
Health-related quality of life (HRQoL)
HRQoL will be measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30). The questionnaire includes five functional domains (physical, role, cognitive, emotional and social), three symptom domains (fatigue, pain, nausea and vomiting) and a global health/quality of life scale. In addition, there are six separate items assessing dyspnea, insomnia, appetite loss, constipation, diarrhea, and perceived financial impact. For each domain and single item measure, a score from 0 to 100 can be calculated. For the functional domains and the global score, higher scores indicate a higher level of functioning/ better quality of life. In contrast, for the symptom domains and single item measures, a higher score represents a higher level of symptomatology.
Measured: 3 years after treatment initiation
Secondary outcomes (3)
Cost-effectiveness
A cost-utility analysis (CUA) will be conducted from a societal and medical perspective. The societal perspective will specifically focus on the patients out of pocket costs. Utilities will be derived by means of a mapping algorithm for the EORTC QLQ-C30. The derived utility will be used to estimate a Quality adjusted life year (QALY) according to the trapezium rule. Incremental costs between EBRT combined with ADT and RARP will be related to incremental QALYs in a cost-utility ratio (ICUR).
Measured: 3 years after treatment initiation
Progression-free survival
Measured: 5 years after diagnosis
Distant metastases-free survival
Measured: 5 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start16 Feb 2023
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- 837 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Comprehensive Cancer Centre The Netherlands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berdine Heesterman, Comprehensive Cancer Centre The Netherlands
- Investigators
- Katja Aben, PhD, Principal investigator, Comprehensive Cancer Centre The NetherlandsIgle Jan de Jong, MD, PhD, Principal investigator, University Medical Center GroningenFloris Pos, MD, PhD, Principal investigator, Netherlands Cancer Institute/ Antoni van LeeuwenhoekBerdine Heesterman, MD, PhD, Principal investigator, Comprehensive Cancer Centre The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931419
- Sponsor's protocol ID
- 2022-13682
- Acronym
- RECOVER
- Status last verified
- Mar 2026
- First submitted
- 26 Apr 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Starre CM, Bangma CH, Bijlsma MJ, van den Bergh ACM, Kiemeney LALM, Kievit W, Vos K, Somford DM, Wildeman SM, Aben KKH, de Jong IJ, Pos FJ, Heesterman BL. External beam radiation therapy versus radical prostatectomy for high-risk prostate cancer: protocol of the RECOVER study. BMC Cancer. 2025 Jan 27;25(1):149. doi: 10.1186/s12885-025-13511-7.
PubMed 39871169
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Risk prostatE Cancer radiatiOn Versus surgERy (RECOVER)
- ClinicalTrials.gov ID
- NCT05931419
- Acronym / sponsor ID
- RECOVER / 2022-13682
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- Radical prostatectomy, Radiotherapy, Health-related quality of life, Functional outcomes, Progression-free survival, Distant metastases-free survival, Cost-effectiveness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 837 participants (estimated)
- Lead sponsor
- Comprehensive Cancer Centre The NetherlandsUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 5 Jul 2023 (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.
Prospective cohort study comparing robot-assisted radical prostatectomy and external beam radiotherapy +/- androgen deprivation therapy for high-risk non-metastatic prostate cancer in terms of health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival and distant metastasis-free survival.
Detailed description
Detailed description: Robot assisted radical prostatectomy (RARP) and external beam radiotherapy (EBRT) often combined with Androgen Deprivation Therapy (ADT) are widely used treatment modalities for high-risk non-metastatic prostate cancer (HR-PCa). Both treatments are associated with adverse effects and can have a great impact on health-related quality of life (HRQoL). To date there is no consensus on which of both is the optimal treatment for men with HR-PCa, as it is unclear which treatment is superior in terms of HRQoL, cost-effectiveness, progression-free survival (PFS) and distant metastases-free survival (DMFS). This is reflected in substantial variation between individual hospitals in the utilization of both treatment options that is not explained by patient- and tumor characteristics or patient preferences. In the RECOVER study we aim to address this knowledge gap. The insights gained can be used to tailor recommendations in (national) guidelines and in shared decision-making tools. This allows healthcare professionals to better inform their patients and allows patients to make well-informed choices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot assisted radical prostatectomy (RARP) | – | –Robot-assisted radical prostatectomy, potentially as part of multimodality therapy with adjuvant radiotherapy or with (neo)adjuvant androgen deprivation therapy. Pelvic lymph node dissection (PLND) may be performed for staging purposes. The presence of positive lymph nodes (pN1) upon PLND is not a reason for exclusion and may be followed by adjuvant treatment such as lymph node irradiation. |
| External beam radiotherapy (EBRT) +/- androgen deprivation therapy (ADT) | – | –External beam radiotherapy (hypofractionated or conventionally fractionated) at a biologically effective dose converted to 2Gy fractions (α/β:1.5) of at least 76Gy. EBRT may also be combined with a brachytherapy boost and PLND may be performed for staging purposes. The presence of positive lymph nodes (pN1) upon PLND is not a reason for exclusion and lymph node irradiation may be performed. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with de novo non-metastatic high-risk prostate cancer (cT3a-bN0M0 and/or ISUP grade ≥4 and/or PSA >20ng/ml), who have opted for treatment with RARP or EBRT +/- ADT and are diagnosed in, or are referred to one of the participating hospitals
Key inclusion criteria (7 listed)
- Histologically confirmed de novo non-metastatic high-risk prostate cancer.
- cT3a-bN0M0, according to the 8th edition of the Tumour, Node, Metastasis (TNM) classification, with the exception that clinical T-stage will be based on digital rectal examination and magnetic resonance imaging (the highest stage will be used) and/or
- International Society of Urological Pathology (ISUP) grade ≥4 and/or
- Prostate-Specific Antigen (PSA) value at diagnosis greater than 20 ng/mL
- Fit for treatment with either RARP or EBRT +/- ADT (WHO performance status 0-1)
Key exclusion criteria (3 listed)
- Histological types other than adenocarcinoma
- Diagnosis and/or treatment in a hospital abroad
- Treatment with Androgen Receptor Targeted Agents (ARTA) as part of the initial treatment plan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional outcomes
Time frame: 3 years after treatment initiation
Functional outcomes will be measured with the Expanded Prostate Cancer Index Composite Short Form (EPIC-26). The EPIC-26 consists of 5 domains: urinary incontinence, urinary irritation, bowel function, sexual function and hormonal function. Domain scores range from 0-100 (the higher the score the better the function) and the minimally clinically important difference (MCID) per domain is 6-9, 5-7, 4-6, 10-12 and 4-6, respectively.
Health-related quality of life (HRQoL)
Time frame: 3 years after treatment initiation
HRQoL will be measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30). The questionnaire includes five functional domains (physical, role, cognitive, emotional and social), three symptom domains (fatigue, pain, nausea and vomiting) and a global health/quality of life scale. In addition, there are six separate items assessing dyspnea, insomnia, appetite loss, constipation, diarrhea, and perceived financial impact. For each domain and single item measure, a score from 0 to 100 can be calculated. For the functional domains and the global score, higher scores indicate a higher level of functioning/ better quality of life. In contrast, for the symptom domains and single item measures, a higher score represents a higher level of symptomatology.
3 secondary outcomes
Cost-effectiveness
Time frame: 3 years after treatment initiation
Progression-free survival
Time frame: 5 years after diagnosis
Distant metastases-free survival
Time frame: 5 years after diagnosis
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 22 May 2026.
- Derived from this study: PubMed 39871169van der Starre CM, Bangma CH, Bijlsma MJ, van den Bergh ACM, Kiemeney LALM, Kievit W, Vos K, Somford DM, Wildeman SM, Aben KKH, de Jong IJ, Pos FJ, Heesterman BL. External beam radiation therapy versus radical prostatectomy for high-risk prostate cancer: protocol of the RECOVER study. BMC Cancer. 2025 Jan 27;25(1):149. doi: 10.1186/s12885-025-13511-7.
Related trials for Prostate Cancer
Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Active, not recruitingObservational study
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
Prostate Cancer, Prostatic Neoplasms
Active, not recruitingPhase 2
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Prostate Cancer
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.
Katja Aben, PhD principal investigator
Comprehensive Cancer Centre The Netherlands
Igle Jan de Jong, MD, PhD principal investigator
University Medical Center Groningen
Floris Pos, MD, PhD principal investigator
Netherlands Cancer Institute/ Antoni van Leeuwenhoek
28 sites 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 and Prostate Adenocarcinoma, run by Comprehensive Cancer Centre The Netherlands at 28 sites 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 7 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites 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?
Contact Berdine Heesterman, MD, PhD (316 39 27 71 73, b.heesterman@iknl.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcomes (time frame: 3 years after treatment initiation). The study lists 2 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 NCT05931419, which also lists 1 linked publication.
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 22 May 2026.