Prostate CancerPhase 3ALADDINNCT05116475
Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases
A Phase 3 study testing Darolutamide 300 mg in people with Prostate Cancer, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 1 site in France.
Trial summary
Prospective, multicenter, comparative, randomized placebo-controlled Phase III trial - patients with hormone-naïve prostate cancer and pelvic lymph nodes metastases Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Darolutamide 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2022to Feb 2027
- Phase
- Phase 3
- 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 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Newly diagnosed, histologically confirmed prostate adenocarcinoma
- ≥ 18 years old.
- Initial staging with Pelvic MRI, body CT-scan/bone scan or Choline or PSMA PET-CT
- Any T stage
- N stage: N1 - Pelvis lymph nodes metastases (upper limit defined as the L4/L5 interspace).
- Intention to treat with long-term androgen deprivation therapy (24 months).
Show all 15Show fewer
- Hormonal therapy with LH-RH agonist or antagonist is allowed up to 3months prior to randomization.
- Able to receive protocol therapy and have life expectancy of at least 36 months, ECOG Performance Status (PS) 0-2.
- . Blood counts at screening: hemoglobin ≥ 9.0 g/dl, absolute neutrophil count ≥ 1500/μl (1.5x109/l), platelet count ≥ 100,000/μl (100x109/l ) (patient must not have received any growth factor or blood transfusion within 7 days of the hematology laboratory obtained at screening).
- Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) < 2.5 x upper limit of normal (ULN), total bilirubin < 1.5 x ULN (except patients with a diagnosis of Gilbert's disease), creatinine < 2.0 x ULN.
- Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method during the study treatment and for 3 months after the end of the study treatment.
- Written informed consent.
- Willing and expected to comply with follow-up schedule.
- Affiliated to the social security system.
- Use of 5-α reductase inhibitors (finasteride, dutasteride) is allowed
Who cannot join
- Lymph nodes metastases outside of the pelvis
- Bone or visceral metastases
- Prior systemic therapy for locally-advanced prostate cancer except for LH-RH agonist or antagonist up to 3 months before randomization
- Prior treatment with:
- Second generation AR inhibitors such as enzalutamide, apalutamide (ARN-509), darolutamide (ODM-201) other investigational AR inhibitors
- CYP17 enzyme inhibitor such as abiraterone acetate, TAK-700 or
Show all 25Show fewer
- Oral ketoconazole
- Use of estrogens, or AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate)
- Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days before randomization.
- Patients with QTor QTc interval > 450 ms on the ECG
- Initiation of treatment with bisphosphonate or denosumab within 12 weeks before randomization. Patients receiving bone loss prevention treatment on a stable dose of e.g. bisphosphonate or denosumab for at least 28 days before randomization can continue the treatment during the study.
- Known hypersensitivity to the study treatment (RT, ADT, darolutamide/placebo) or any of its ingredients.
- Major surgery within 28 days before randomization.
- Any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV or arterial thromboembolic event.
- Uncontrolled hypertension as indicated by a resting systolic BP > 160 mmHg or diastolic BP > 100 mmHg at screening. Patients may be re-screened after adjustments of anti- hypertensive medications.
- Prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e. pTis, pTa, and pT1) is allowed, as well as any other cancer for which chemotherapy has been completed > 5 years ago and from which the patient has been disease-free.
- Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
- Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
- Participation in another interventional clinical trial and any concurrent treatment with any investigational drug
- Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.
- Unable to swallow study medications and comply with study requirements.
- Galactose intolerance, the Lapp lactase deficiency or glucose galactose-malabsorption
- History of bilateral hip replacements making IMRT impossible
- Contra-indications for the administration of any of the study treatments (RT, ADT, Darolutamide/placebo) or any of its ingredients.
- Patient under guardianship, administrative tutorship and incapable to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Pôle Santé Léonard de Vinci
Chambray-lès-Tours, 37170
Pierre COMBE, MD, p.combe@cort37.fr
About this study
Prospective, multicenter, comparative, randomized placebo-controlled Phase III trial - patients with hormone-naïve prostate cancer and pelvic lymph nodes metastases
Read the detailed description
Standard of care for patients with prostate cancer (PC) with pelvic lymph nodes metastases is radiotherapy (RT) with long-term androgen deprivation therapy (ADT). . Darolutamide improves survival in men with castration-refractory non metastatic prostate cancer. We hypothesize that adding Darolutamide to ADT and RT could improve FFS for these high-risk patients.
- Conditions
- Prostate Cancer
- Being tested
- Darolutamide 300 mg, Placebo of Darolutamide
- Keywords
- Prostate cancer, Darolutamide, ARTIC, Bayer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darolutamide 300 mgDrug
Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months.
Placebo of DarolutamideDrug
Placebo of Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Arm A: ADT + Intensity-Modulated Image-Guided Radiation Therapy + Darolutamide ADT will be associated with LHRH agonists or antagonists for 24 months4. Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months. Receives: Drug: Darolutamide 300 mg |
| Arm B | Placebo comparator | Arm B: ADT + Intensity-Modulated Image-Guided Radiation Therapy + Placebo of Darolutamide
ADT will be associated with LHRH agonists or antagonists for 24 months4. Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months. Receives: Drug: Placebo of Darolutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-free survival FFS
The failure-free survival is defined as the time from the date of randomization to clinical (new cancer-related symptoms), biochemical (PSA rising) or radiological (local relapse or new metastases) progression, death, end of 3-year follow-up period or lost to follow-up, whichever occurs first.
Measured: 3 years
Secondary outcomes (10)
Metastasis-free survival rates
To evaluate the metastasis-free survival rates
Measured: 3 years
Progression free survival rate
To evaluate the progression free survival rates
Measured: 3 years
PSA response levels
PSA response is defined by the rate of patients having a decrease of > 50% of their PSA level, as measured every 3 months from the date of randomization to the date of a documented biochemical relapse.
Measured: 3 years
Overall survival rates
Overall survival is defined as the time from the date of randomization to the date of documented death from any cause, end of 3-year follow-up period or lost to follow-up, whichever occurs first
Measured: 3 years
Cancer-specific survival rates
Cancer-specific survival is defined as the time from the date of randomization to the date of documented death from prostate cancer or complication from the treatment, end of 3-year follow-up period or lost to follow-up, whichever occurs first
Measured: 3 years
Time to pain progression
Time to pain progression is defined as the time from the date of randomization to the date of documented pain, end of 3-year follow-up period or lost to follow-up, whichever occurs first
Measured: 3 years
Toxicities
To evaluate toxicities (CTCAE v5.0) due to treatements
Measured: 3 years
Quality of life of the patient
Quality of life will be assessed using self-administered questionnaires (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire : EORTC QLQ-C30 v2)
Measured: 3 years
Quality of life of the patient
Quality of life will be assessed using self-administered questionnaires (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire : EORC QLQ-PR25 V3)
Measured: 3 years
Quality of life of the participants
Quality of life will be assessed using self-administered questionnaires (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire : EORTC QLQ-PR253) by patients
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start30 Aug 2022
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Pierre COMBE, MD, Principal investigator, Centre Oncologie Radiothérapie 37 - CORT37
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116475
- Sponsor's protocol ID
- ALADDIN
- Acronym
- ALADDIN
- Status last verified
- Mar 2024
- First submitted
- 27 Oct 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases
- ClinicalTrials.gov ID
- NCT05116475
- Acronym / sponsor ID
- ALADDIN / ALADDIN
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Darolutamide, ARTIC, Bayer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Association Pour La Recherche des Thérapeutiques Innovantes en CancérologieUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 11 Nov 2021 (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, multicenter, comparative, randomized placebo-controlled Phase III trial - patients with hormone-naïve prostate cancer and pelvic lymph nodes metastases
Detailed description
Standard of care for patients with prostate cancer (PC) with pelvic lymph nodes metastases is radiotherapy (RT) with long-term androgen deprivation therapy (ADT). . Darolutamide improves survival in men with castration-refractory non metastatic prostate cancer. We hypothesize that adding Darolutamide to ADT and RT could improve FFS for these high-risk patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Darolutamide 300 mgArm A: ADT + Intensity-Modulated Image-Guided Radiation Therapy + Darolutamide ADT will be associated with LHRH agonists or antagonists for 24 months4. Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months. |
| Arm B | Placebo comparator | Drug: Placebo of DarolutamideArm B: ADT + Intensity-Modulated Image-Guided Radiation Therapy + Placebo of Darolutamide ADT will be associated with LHRH agonists or antagonists for 24 months4. Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- . Newly diagnosed, histologically confirmed prostate adenocarcinoma
- ≥ 18 years old.
- Initial staging with Pelvic MRI, body CT-scan/bone scan or Choline or PSMA PET-CT
- Any T stage
- N stage: N1 - Pelvis lymph nodes metastases (upper limit defined as the L4/L5 interspace).
Key exclusion criteria (25 listed)
- Lymph nodes metastases outside of the pelvis
- Bone or visceral metastases
- Prior systemic therapy for locally-advanced prostate cancer except for LH-RH agonist or antagonist up to 3 months before randomization
- Prior treatment with:
- Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days before randomization.
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 |
|---|---|---|
| Darolutamide 300 mgDarolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months. | Drug | Arm A |
| Placebo of DarolutamidePlacebo of Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months. | Drug | Arm B |
Primary outcome
Failure-free survival FFS
Time frame: 3 years
The failure-free survival is defined as the time from the date of randomization to clinical (new cancer-related symptoms), biochemical (PSA rising) or radiological (local relapse or new metastases) progression, death, end of 3-year follow-up period or lost to follow-up, whichever occurs first.
10 secondary outcomes
Metastasis-free survival rates
Time frame: 3 years
Progression free survival rate
Time frame: 3 years
PSA response levels
Time frame: 3 years
Overall survival rates
Time frame: 3 years
Cancer-specific survival rates
Time frame: 3 years
Time to pain progression
Time frame: 3 years
Toxicities
Time frame: 3 years
Quality of life of the patient
Time frame: 3 years
Quality of life of the patient
Time frame: 3 years
Quality of life of the participants
Time frame: 3 years
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 12 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Pierre COMBE, MD principal investigator
Centre Oncologie Radiothérapie 37 - CORT37
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darolutamide 300 mg in people with Prostate Cancer, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 1 site in France.
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 15 inclusion and 25 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 12 Mar 2024. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ishak Senouci (0766185461, ishak.senouci@association-artic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure-free survival FFS (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.