Prostate Cancer (Diagnosis)Phase 2NCT07299292
Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)
A Phase 2 study testing Abiraterone 250 mg with food + prednisone in people with Prostate Cancer (Diagnosis), run by SMED Clinical Research at 3 sites in 2 countries.
Trial summary
Hypothesis The use of Abiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis)
- What is being tested?
- Abiraterone 250 mg with food + prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Dec 2025to 30 Mar 2027
- Phase
- Phase 2
- 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
- Age ≥18 years.
- Histologically confirmed prostate adenocarcinoma.
- Treated at Hospital Durand (Argentina) or Instituto Oncológico del Oriente Boliviano (Bolivia).
- Indicated for hormonal intensification (high/very high risk candidates for RT, or mHSPC for doublet/triplet).
- No prior ADT.
- ECOG 0-2; adequate hepatic/renal function; K+ ≥3.5 mmol/L; controlled BP.
Who cannot join
- Hypersensitivity to ABI/prednisone; moderate-severe hepatic impairment; uncontrolled hypertension; refractory hypokalemia.
- Concurrent therapy with strongly contraindicated/inducing drugs affecting ABI levels without possibility of adjustment.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital San José
Hermosillo
Danny Mena, MD, +527291081110, dmena@theranuks.com
dmena@theranuks.com
- Recruiting
Instituto Oriente Boliviano
Santa Cruz de la Sierra, 10260
Lucía Ritcher Lucia Ritcher, MD, +5491149940783, smeclinicalresearch@gmail.com
Lucia Ritcher
Argentina1 site, 1 recruiting
- Recruiting
Hospital Carlos A Durand
Buenos Aires, 5044
Diego Barreiro, MD, +5491149940794, diegomartinbarreiro@hotmail.com
About this study
Hypothesis
The use of Abiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases.
Read the detailed description
Design
- Type: Phase 2, prospective, open-label, multicenter, single-cohort.
- Inclusion Criteria:
- Patients with standard indication for intensification:
- M0 high/very high risk candidates for RT (Abiraterone [ABI] for 2 years + ADT for 3 years per STAMPEDE), or
- mHSPC: candidates for doublet (ADT+ABI) or triplet (ADT+Docetaxel+ABI); without ADT during the first 30 days.
Objectives and Endpoints
Primary:
- Proportion of patients with serum testosterone ≤50 ng/dL (and sensitivity analysis ≤20 ng/dL) at Day 30 (±3) without receiving ADT.
- Time to castration (first day with T ≤50 ng/dL within D1-D30).
Secondary:
- Absolute and % change in PSA between D0 and D30; PSA50 and PSA90 rates at D30.
- Safety (CTCAE v5.0): hypertension, hypokalemia, hepatotoxicity, fluid retention, adrenal insufficiency.
Procedures and Timeline
- Screening (≤7 days): consent, medical history, ECOG, BP, ECG, labs: CBC, liver profile, creatinine, K+, PSA, testosterone.
- Day 0: start ABI 250 mg + prednisone 5-10 mg/day; education on "with food" administration.
- Day 30 (±3): AE, BP, K+, LFT, T, PSA → endpoint evaluation.
- Safety follow-up: until Day 60.
Ethical and Regulatory Considerations
- In Argentina and Bolivia, time to access intensified treatment with Abiraterone (doublet or triplet) exceeds two months in the public system, so waiting time is not altered and patients may benefit from early intensified castration if trial is positive.
- The 250 mg "with food" regimen has pharmacokinetic/economic support in literature; detailed in consent. Multiple studies confirm ABI 250 mg with food equals 1000 mg, and NCCN guidelines recommend this dosing in low-access settings. The SPARE study evaluated safety of ABI without ADT in metastatic castration-resistant prostate cancer, showing equivalence.
- The 30-day window without LHRH is limited, and all patients will receive standard treatment.
Rescue and Safety Criteria • Key AE management:
- Hypokalemia: supplement; consider eplerenone (preferred over spironolactone for lower androgenic interaction); adjust steroid.
- Hypertension: optimize antihypertensives.
- Hepatotoxicity: pauses/adjustments per AAP guidelines.
Sample Size and Justification
- One-sample binomial test to reject p≤0.70 (unacceptable null) in favor of p≥0.90 (target).
- With n=24 per cohort and success defined as ≥20/24 patients achieving castration at D30:
- α (one-sided) ≈ 0.042 if true p=0.70.
- Power ≈ 0.91 if true p=0.90.
Variables and Analysis
- Primary: proportion with T ≤50 ng/dL at D30 (main analysis) and T ≤20 ng/dL (sensitivity).
- Estimate 95% CI and one-sided binomial test vs 70%. Cohort success if ≥20/24 meet criteria.
- Secondary:
- PSA: absolute and % change, PSA50/PSA90 rates at D30.
- Safety: AE rates (CTCAE v5.0).
Quality and Logistics
- Testosterone measurement (validated method; preferably LC-MS/MS) to avoid variability.
- Written instructions for administration with food (same time, similar meal).
- Home BP and AE recording (card/app).
- Conditions
- Prostate Cancer (Diagnosis)
- Being tested
- Abiraterone 250 mg with food + prednisone
- Keywords
- prostate cancer, castration, abiraterone, hormonal intensification
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone 250 mg with food + prednisoneDrug
Abiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases
| Study group | Role | What they receive |
|---|---|---|
| single-cohort | Experimental | Abiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases. Receives: Drug: Abiraterone 250 mg with food + prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Response per PCWG3
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- * Initial Intervention (Day 0-40): * Day 0: Testosterone and PSA measurement. * Abiraterone acetate 250 mg PO with lunch. * Prednisone 5-10 mg/day (either 5 mg/day or 5 mg every 12 h, at investigator's discretion). * No ADT until completion of Day 30 evaluation. * After Day 30: * If the patient achieves castration (primary endpoint met) or not, continue standard indicated treatment (add ADT from Day 31, continue AAP as planned, ± docetaxel/AAP).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SMED Clinical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299292
- Sponsor's protocol ID
- TN-2025-0003
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Castration With Abiraterone 250 mg Without LHRH Analogs or Blockers in Patients With Prostate Cancer Requiring Hormonal Intensification (Multicenter Phase 2)
- ClinicalTrials.gov ID
- NCT07299292
- Acronym / sponsor ID
- TN-2025-0003
- Conditions
- Prostate Cancer (Diagnosis)
- Keywords
- prostate cancer, castration, abiraterone, hormonal intensification
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SMED Clinical ResearchUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 23 Dec 2025 (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.
Hypothesis
The use of Abiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases.
Detailed description
Design
- Type: Phase 2, prospective, open-label, multicenter, single-cohort.
- Inclusion Criteria:
- Patients with standard indication for intensification:
- M0 high/very high risk candidates for RT (Abiraterone [ABI] for 2 years + ADT for 3 years per STAMPEDE), or
- mHSPC: candidates for doublet (ADT+ABI) or triplet (ADT+Docetaxel+ABI); without ADT during the first 30 days.
Objectives and Endpoints
Primary:
- Proportion of patients with serum testosterone ≤50 ng/dL (and sensitivity analysis ≤20 ng/dL) at Day 30 (±3) without receiving ADT.
- Time to castration (first day with T ≤50 ng/dL within D1-D30).
Secondary:
- Absolute and % change in PSA between D0 and D30; PSA50 and PSA90 rates at D30.
- Safety (CTCAE v5.0): hypertension, hypokalemia, hepatotoxicity, fluid retention, adrenal insufficiency.
Procedures and Timeline
- Screening (≤7 days): consent, medical history, ECOG, BP, ECG, labs: CBC, liver profile, creatinine, K+, PSA, testosterone.
- Day 0: start ABI 250 mg + prednisone 5-10 mg/day; education on "with food" administration.
- Day 30 (±3): AE, BP, K+, LFT, T, PSA → endpoint evaluation.
- Safety follow-up: until Day 60.
Ethical and Regulatory Considerations
- In Argentina and Bolivia, time to access intensified treatment with Abiraterone (doublet or triplet) exceeds two months in the public system, so waiting time is not altered and patients may benefit from early intensified castration if trial is positive.
- The 250 mg "with food" regimen has pharmacokinetic/economic support in literature; detailed in consent. Multiple studies confirm ABI 250 mg with food equals 1000 mg, and NCCN guidelines recommend this dosing in low-access settings. The SPARE study evaluated safety of ABI without ADT in metastatic castration-resistant prostate cancer, showing equivalence.
- The 30-day window without LHRH is limited, and all patients will receive standard treatment.
Rescue and Safety Criteria • Key AE management:
- Hypokalemia: supplement; consider eplerenone (preferred over spironolactone for lower androgenic interaction); adjust steroid.
- Hypertension: optimize antihypertensives.
- Hepatotoxicity: pauses/adjustments per AAP guidelines.
Sample Size and Justification
- One-sample binomial test to reject p≤0.70 (unacceptable null) in favor of p≥0.90 (target).
- With n=24 per cohort and success defined as ≥20/24 patients achieving castration at D30:
- α (one-sided) ≈ 0.042 if true p=0.70.
- Power ≈ 0.91 if true p=0.90.
Variables and Analysis
- Primary: proportion with T ≤50 ng/dL at D30 (main analysis) and T ≤20 ng/dL (sensitivity).
- Estimate 95% CI and one-sided binomial test vs 70%. Cohort success if ≥20/24 meet criteria.
- Secondary:
- PSA: absolute and % change, PSA50/PSA90 rates at D30.
- Safety: AE rates (CTCAE v5.0).
Quality and Logistics
- Testosterone measurement (validated method; preferably LC-MS/MS) to avoid variability.
- Written instructions for administration with food (same time, similar meal).
- Home BP and AE recording (card/app).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * Initial Intervention (Day 0-40): * Day 0: Testosterone and PSA measurement. * Abiraterone acetate 250 mg PO with lunch. * Prednisone 5-10 mg/day (either 5 mg/day or 5 mg every 12 h, at investigator's discretion). * No ADT until completion of Day 30 evaluation. * After Day 30: * If the patient achieves castration (primary endpoint met) or not, continue standard indicated treatment (add ADT from Day 31, continue AAP as planned, ± docetaxel/AAP).
| Arm | Type | Receives |
|---|---|---|
| single-cohort | Experimental | Drug: Abiraterone 250 mg with food + prednisoneAbiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Histologically confirmed prostate adenocarcinoma.
- Treated at Hospital Durand (Argentina) or Instituto Oncológico del Oriente Boliviano (Bolivia).
- Indicated for hormonal intensification (high/very high risk candidates for RT, or mHSPC for doublet/triplet).
- No prior ADT.
Key exclusion criteria (2 listed)
- Hypersensitivity to ABI/prednisone; moderate-severe hepatic impairment; uncontrolled hypertension; refractory hypokalemia.
- Concurrent therapy with strongly contraindicated/inducing drugs affecting ABI levels without possibility of adjustment.
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 |
|---|---|---|
| Abiraterone 250 mg with food + prednisoneAbiraterone 250 mg with food + prednisone, without LHRH analogs or blockers (ADT), achieves castration-level testosterone at 30 days in ≥80-90% of cases | Drug | single-cohort |
Primary outcome
Response rate
Time frame: 3 months
Response per PCWG3
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 23 Dec 2025.
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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.
Instituto Oriente Boliviano
Santa Cruz de la Sierra, Spain
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abiraterone 250 mg with food + prednisone in people with Prostate Cancer (Diagnosis), run by SMED Clinical Research at 3 sites in 2 countries.
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 6 inclusion and 2 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Argentina. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 3 months). 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 23 Dec 2025.