Prostate CAPhase 1NCT06631521
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
A Phase 1 study testing Darolutamide, Relugolix and Radical Prostatectomy in people with Prostate CA and Prostate Cancer (Adenocarcinoma), run by AdventHealth at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in adult males. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate CA, Prostate Cancer (Adenocarcinoma), Prostate Cancer Surgery
- What is being tested?
- Darolutamide, Relugolix and Radical Prostatectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2024to Jun 2026
- Phase
- Phase 1
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- ECOG performance status 0-1
- Ability to swallow oral medications and comply with study procedures and requirements.
- Males ≥18 years
- Participants must have adequate organ and marrow function as below:
- Absolute neutrophil count (ANC) ≥1,500/mm3 or ≥1.5 x 109/L;
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- Platelets ≥100,000/mm3 or ≥100 x 109/L;
- Hemoglobin ≥8 g/dL (may have been transfused).
- Estimated creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation.
- Total serum bilirubin \<1.5 x upper limit of normal (ULN), less than 2.0 x ULN if suspected Gilbert's syndrome;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN.
- Must be a candidate for RP
- Clinical stage cT2-4, N0-1
- Mandatory to identify tumor availability (≥10 FFPE slides, 5 µM thickness \& 1 stained H\&E slide OR tumor block)
- High-risk PCa defined as one of the following-
- Gleason score (GS) ≥ 4 + 3 with ≥ 6 positive systematic biopsies (SB)
- GS ≥ 4 + 3 with ≥ 3 SB and prostate-specific antigen (PSA) ≥ 20 ng/mL
- GS ≥ 9 in ≥ 1 SB or targeted biopsies (TB) -≥ 2 SB or TB with continuous GS ≥ 8, each with ≥ 80% involvement.
Who cannot join
- Histologic variants including neuroendocrine differentiation, small cell, sarcomatoid, ductal adenocarcinoma, squamous or transitional cell carcinoma) comprising more than 50% of the sample as determined by pathology review
- Participants who have had chemotherapy or radiotherapy within 4 weeks prior to planned cycle 1 day 1 of study treatment.
- Participants who have received anti-neoplastic intervention or experimental antineoplastic therapy within 14 days of planned cycle 1 day 1 of study therapy.
- Participants who are receiving any other investigational agents.
- Participants who have previously received darolutamide, relugolix, LHRH agonist/antagonist or another novel androgen blocking therapy (abiraterone, apalutamide, enzalutamide) within 1 year are excluded (prior bicalutamide that was discontinued ≥14 days prior to planned cycle 1 day 1 is allowed).
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e. have residual toxicities ≥Grade 2) with the exception of alopecia.
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- Any of the following within 6 months before planned cycle 1 day 1 of study therapy:
- Stroke
- Myocardial infarction
- Severe/unstable angina pectoris
- Coronary/peripheral artery bypass graft
- Congestive heart failure New York Heart Association (NYHA) Class III or IV.
- Known or suspected contraindications, hypersensitivity or allergy to darolutamide or relugolix or to any of their excipients.
- Participants with hepatitis C, hepatitis B or human immunodeficiency (HIV) who are on anti-viral therapy that has the potential to interact with darolutamide or relugolix.
- Participants treated with drugs known to be strong inhibitors and/or inducers of cytochrome P450 3A4 (CYP3A4) and the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to starting study drug.
- NOTE: precaution is warranted with concomitant use of agents with a narrow therapeutic index that are substrates of P-gp, BCRP and OCT1.
- The participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance less than 30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
- Concurrent active malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of the investigational regimen. Patients with non-melanomatous skin cancer, superficial bladder cancer, cancer not needing active therapy for at least 2 years, cancer for which the treating investigator deems the subject to be in remission, or any prior malignancy that was treated with curative intent (no evidence of disease for at least 3 years) are permitted to enroll.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
AdventHealth Oncology Research, 407-303-2090, CFD.ResearchOncology@AdventHealth.com
About this study
Official title: Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for High Risk Localized and Locally Advanced Prostate Cancer: A Phase I/Ib Trial
The goal of this clinical trial is to determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in adult males.
- Being tested
- Darolutamide, Relugolix, Radical Prostatectomy
- Keywords
- Prostate Cancer, High-Risk Prostate Cancer, Neoadjuvant Therapy, Radical Prostatectomy, Darolutamide, Relugolix, Androgen Receptor Antagonists, Gonadotropin-Releasing Hormone Antagonists, Clinical Trial Phase I/Ib, PSA Response
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarolutamideDrug
Also called Nubeqa, BAY 1841788
600 mg (two 300 mg tablets) taken orally twice daily.
RelugolixDrug
A loading dose of 360 mg on the first day, followed by 120 mg taken orally once daily.
Radical ProstatectomyProcedure or surgery
Performed at least 48 hours and within 2 weeks after the completion of neoadjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy Arm | Experimental | This arm is designed to evaluate the safety and feasibility of the combination therapy using darolutamide and relugolix as neoadjuvant treatment before radical prostatectomy (RP) in patients with high-risk prostate cancer (PCa). Receives: Drug: Darolutamide; Drug: Relugolix; Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients completing therapy without severe adverse events.
Measured: From enrollment, up to 8 weeks after radical prostatectomy.
Number of patients experiencing treatment-related adverse events using CTCAE version 5.0.
Measured: From enrollment, up to 8 weeks following radical prostatectomy (RP)
Secondary outcomes (3)
Objective Radiographic Response
Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes in millimeters (mm). Response refers to the reduction in tumor size according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) criteria (Complete Response, Partial Response, Stable Disease, or Progressive Disease).
Measured: From enrollment, up to 12 weeks (end of neoadjuvant therapy).
Prostate-specific antigen (PSA) Response
The unit of measure is nanograms per milliliter (ng/mL). A PSA response is defined as a decline of ≥50% from baseline levels.
Measured: From enrollment, up to 8 weeks after radical prostatectomy.
Plasma Concentration of Darolutamide and Relugolix
This measure involves assessing the plasma concentration of darolutamide and relugolix at specified time points to determine their pharmacokinetic profiles. Units of measure: Concentration in nanograms per milliliter (ng/mL).
Measured: From enrollment, up to Day 1 of Cycle 3 (Each cycle is 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start22 Oct 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CAStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Sumitomo Pharma Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631521
- Sponsor's protocol ID
- IIR-US-00295
- Other IDs
- 2077841
- Status last verified
- Jan 2026
- First submitted
- 3 Oct 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for High Risk Localized and Locally Advanced Prostate Cancer: A Phase I/Ib Trial
- ClinicalTrials.gov ID
- NCT06631521
- Acronym / sponsor ID
- IIR-US-00295
- Keywords
- Prostate Cancer, High-Risk Prostate Cancer, Neoadjuvant Therapy, Radical Prostatectomy, Darolutamide, Relugolix, Androgen Receptor Antagonists, Gonadotropin-Releasing Hormone Antagonists
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- Bayer, Sumitomo Pharma Switzerland
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 8 Oct 2024 (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 goal of this clinical trial is to determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in adult males.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy Arm | Experimental | Drug: Darolutamide, Drug: Relugolix, Procedure: Radical ProstatectomyThis arm is designed to evaluate the safety and feasibility of the combination therapy using darolutamide and relugolix as neoadjuvant treatment before radical prostatectomy (RP) in patients with high-risk prostate cancer (PCa). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- ECOG performance status 0-1
- Ability to swallow oral medications and comply with study procedures and requirements.
- Males ≥18 years
- Participants must have adequate organ and marrow function as below:
Key exclusion criteria (18 listed)
- Histologic variants including neuroendocrine differentiation, small cell, sarcomatoid, ductal adenocarcinoma, squamous or transitional cell carcinoma) comprising more than 50% of the sample as determined by pathology review
- Participants who have had chemotherapy or radiotherapy within 4 weeks prior to planned cycle 1 day 1 of study treatment.
- Participants who have received anti-neoplastic intervention or experimental antineoplastic therapy within 14 days of planned cycle 1 day 1 of study therapy.
- Participants who are receiving any other investigational agents.
- Participants who have previously received darolutamide, relugolix, LHRH agonist/antagonist or another novel androgen blocking therapy (abiraterone, apalutamide, enzalutamide) within 1 year are excluded (prior bicalutamide that was discontinued ≥14 days prior to planned cycle 1 day 1 is allowed).
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 |
|---|---|---|
| DarolutamideAlso: Nubeqa, BAY 1841788600 mg (two 300 mg tablets) taken orally twice daily. | Drug | Combination Therapy Arm |
| RelugolixA loading dose of 360 mg on the first day, followed by 120 mg taken orally once daily. | Drug | Combination Therapy Arm |
| Radical ProstatectomyPerformed at least 48 hours and within 2 weeks after the completion of neoadjuvant therapy. | Procedure or surgery | Combination Therapy Arm |
Primary outcome
Percentage of patients completing therapy without severe adverse events.
Time frame: From enrollment, up to 8 weeks after radical prostatectomy.
Number of patients experiencing treatment-related adverse events using CTCAE version 5.0.
Time frame: From enrollment, up to 8 weeks following radical prostatectomy (RP)
3 secondary outcomes
Objective Radiographic Response
Time frame: From enrollment, up to 12 weeks (end of neoadjuvant therapy).
Prostate-specific antigen (PSA) Response
Time frame: From enrollment, up to 8 weeks after radical prostatectomy.
Plasma Concentration of Darolutamide and Relugolix
Time frame: From enrollment, up to Day 1 of Cycle 3 (Each cycle is 28 days).
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 5 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Darolutamide, Relugolix and Radical Prostatectomy in people with Prostate CA and Prostate Cancer (Adenocarcinoma), run by AdventHealth at 1 site in United States.
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 18 inclusion and 18 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 5 Feb 2026. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 AdventHealth Oncology Research (407-303-2090, CFD.ResearchOncology@AdventHealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients completing therapy without severe adverse events. (time frame: From enrollment, up to 8 weeks after radical prostatectomy.). 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?
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 5 Feb 2026.