Castration Sensitive Prostate CancerPhase 2STEPDOWNmHSPCNCT07838753
A Study Testing if Patients With Advanced Prostate Cancer Who Are Responding Well to Combination Treatment Can Safely Reduce Their Medication to a Single Hormone Therapy, Compared to Continuing Their Current Drugs
A Phase 2 study testing De-escalation strategy and Continuation of initial Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) combination therapy at standard doses in people with Castration Sensitive Prostate Cancer and Metastatic Prostate Cancer, run by Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute at 1 site in India.
Trial summary
The goal of this randomized comparative study (a study where participants are placed into groups by chance) is to find out if reducing treatment to androgen deprivation therapy (ADT)-a treatment that lowers testosterone-by itself works just as well as continuing the original combination of drugs. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Castration Sensitive Prostate Cancer, Metastatic Prostate Cancer
- What is being tested?
- De-escalation strategy and Continuation of initial Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) combination therapy at standard doses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2026to Sep 2031
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients of age group 18 to 80 years will be included
- Patients who would voluntarily agree to sign informed consent form
- Histologically confirmed adenocarcinoma of the prostate
- Evidence of metastatic disease at diagnosis (de novo) or after definitive local therapy, documented on PSMA PET/CT
- Intended to receive ADT plus an ARPI (abiraterone, enzalutamide, apalutamide or darolutamide) OR ADT plus ARPI plus docetaxel, as determined by the treating physician prior to enrolment
- ECOG performance status 0-2
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- Adequate organ function: haemoglobin ≥ 9 g/dL; absolute neutrophil count ≥ 1.5 × 10⁹/L; platelets ≥ 100 × 10⁹/L; serum creatinine ≤ 1.5 × ULN or estimated GFR ≥ 45 mL/min; total bilirubin ≤ 1.5 × ULN; AST/ALT ≤ 2.5 × ULN
- Life expectancy ≥ 12 months
- Criteria for randomization ("optimal responder"):
- Completion of 6-7 months of protocol-defined doublet or triplet therapy without unplanned interruption > 30 days
- Serum PSA < 0.2 ng/mL at re-staging
- Serum testosterone at castrate level (< 50 ng/dL)
- PSMA PET/CT demonstrating partial or complete response as per PPP criteria: (i) no new PSMA-avid lesions; (ii) > 30 % decrease in total PSMA tumour volume compared with baseline; and (iii) no progression at existing sites
- ECOG 0-2 at re-staging
- Adequate organ function (as at baseline)
- Ongoing willingness to participate and to comply with randomized treatment
Who cannot join
- Known small-cell, neuroendocrine or predominantly sarcomatoid histology
- Prior systemic therapy for prostate cancer other than ≤ 90 days of ADT (± a short course of first-generation anti-androgen for flare prevention) at enrolment
- Prior treatment with any ARPI, docetaxel, cabazitaxel, Ra-223 or 177Lu-PSMA
- Uncontrolled hypertension (systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg despite therapy), history of seizures or predisposing conditions (for enzalutamide candidates), unstable cardiac disease, recent myocardial infarction or stroke within 6 months
- Known active second malignancy requiring systemic therapy (except adequately treated non-melanoma skin cancer)
- Active uncontrolled infection including HIV, hepatitis B or C with detectable viral load, or tuberculosis on active treatment
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- Any contraindication to the chosen ARPI, docetaxel or ADT per respective product labels
- Psychiatric or cognitive disorder limiting capacity to consent or comply with protocol
- Serum PSA ≥ 0.2 ng/mL or any PSA rise above nadir of ≥ 25 %
- Any new lesion on PSMA PET or conventional imaging
- Progression at existing sites per PCWG4 or PPP
- Testosterone ≥ 50 ng/dL (non-castrate)
- Development of symptomatic disease (e.g. new bone pain requiring opioid therapy, cord compression, pathological fracture)
- Grade ≥ 3 ongoing toxicities attributable to current therapy that precludes continuation
- Withdrawal of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
Mumbai, Maharashtra, 400053
Thyavihally B. Yuvaraja, MBBS, MS, MCh, DNB (Urology), +919321322505, tb.yuvaraja@gmail.com
About this study
Official title: Randomized Phase 2 Assessment of De-escalation to Androgen Deprivation Therapy Alone Versus Continuation of Doublet or Triplet Therapy in Responders With Metastatic Hormone-Sensitive Prostate Cancer
The goal of this randomized comparative study (a study where participants are placed into groups by chance) is to find out if reducing treatment to androgen deprivation therapy (ADT)-a treatment that lowers testosterone-by itself works just as well as continuing the original combination of drugs. This study involves adult men with metastatic hormone-sensitive prostate cancer (prostate cancer that has spread to other parts of the body but still responds to hormone treatments) who have responded very well after 6 to 7 months of their initial two-drug or three-drug treatment.
The main questions it aims to answer are:
Read more
- Does reducing treatment to ADT alone work as well as the combination treatment at keeping the cancer from growing on imaging scans after 18 months, also known as radiographic progression-free survival (rPFS)?
- Does reducing treatment to ADT alone work as well as the combination treatment at preventing a rise in prostate-specific antigen (PSA), known as PSA progression-free survival (PSA-PFS)?
Researchers will compare a continuation group, which continues their initial two-drug or three-drug treatment, to a reduced-treatment group, which stops taking the androgen receptor pathway inhibitor (ARPI)-a drug that blocks the effects of hormones on cancer cells. Researchers want to see if reducing the treatment safely controls the cancer while lowering drug side effects and financial costs.
Participants will:
- Complete a 6- to 7-month initial period receiving a two-drug or three-drug treatment chosen by their doctor.
- Have blood tests for PSA and testosterone, and undergo a specialized imaging scan called a prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) scan, to confirm the treatment is working very well before being assigned to a study group.
- Stop taking the ARPI drug if assigned to the reduced-treatment group, or continue their current medications if assigned to the continuation group.
- Go to check-up visits every 3 months for the first 24 months to complete physical exams, blood tests, and quality-of-life surveys.
- Have a PSMA PET/CT scan every 6 months after being put into a group to check if the cancer has grown.
Read the detailed description
This phase 2 randomized comparative study investigates the de-escalation of systemic therapy for patients with metastatic hormone-sensitive prostate cancer (mHSPC) (STEPDOWNmHSPC i.e. Strategy for Therapy Escalation Pruning in metastatic Hormone Sensitive Prostate Cancer)who have achieved an optimal response to initial treatment.
- Background and Rationale:
In India, 40-60% of patients diagnosed with prostate cancer present with metastatic disease, a significantly higher rate than the 5-10% observed in Western cohorts. While indefinite doublet or triplet therapies (combining androgen deprivation therapy [ADT], androgen receptor pathway inhibitors [ARPI], and sometimes docetaxel) are the standard of care, they cause substantial cumulative physical, metabolic, and financial toxicities. Because a significant sub-population of patients achieves a deep response to these therapies, this trial evaluates whether carefully selected patients can safely de-escalate to ADT monotherapy without compromising oncological outcomes.
- Study Objectives:
- Primary Objective: To determine if de-escalation to ADT monotherapy is non-inferior to continuing doublet or triplet therapy regarding 18-month radiographic progression-free survival (rPFS) and PSA Progression-Free Survival (PSA-PFS).
- Secondary Objectives: To compare overall survival, time to castration-resistant prostate cancer (CRPC), sustained complete PSMA PET responses at 12 and 24 months, quality of life (using EORTC QLQ-C30 i.e. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30), incidence of severe adverse events, and economic burden between the two arms.
- Study Design and Methodology:
- Target Population: Adult men with histologically confirmed prostate adenocarcinoma, an ECOG (Eastern Co-operative Oncology Group) performance status of 0-2, and documented metastatic disease on PSMA PET/CT.
- Run-In Phase: The study will initially enrol approximately 265 patients, who will undergo 6 to 7 months of standard doublet or triplet therapy.
- Randomization: Following the run-in phase, patients who achieve an "optimal response"-defined as a serum PSA < 0.2 ng/mL, castrate testosterone levels (< 50 ng/dL), and a partial or complete response on PSMA PET/CT with no new lesions-will be randomized 1:1 into two arms. The trial targets 170 randomized patients (85 per arm) to account for an estimated 10% attrition rate.
Arm A (Continuation): Patients will continue their initial ADT and ARPI regimen at the same doses.
Arm B (De-escalation): Patients will discontinue the ARPI and continue with ADT monotherapy.
- Statistical Analysis:
To establish non-inferiority, the study utilizes a 15% margin with 80% power and a one-sided alpha of 0.10. Radiographic progression-free survival will be estimated using the Kaplan-Meier method, and treatments will be compared using a stratified log-rank test and Cox proportional hazards regression based on randomization stratification factors. The primary analysis will be performed on both the Intention-To-Treat (ITT) and Per-Protocol (PP) populations, requiring consistent findings in both to declare non-inferiority.
- Being tested
- De-escalation strategy, Continuation of initial Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) combination therapy at standard doses
- Keywords
- Androgen Antagonists, Prostate-Specific Antigen, Metastatic Hormone-Sensitive Prostate Cancer, Androgen Deprivation Therapy, Androgen Receptor Pathway Inhibitors
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-escalation strategyOther
The experimental intervention is a response-adapted de-escalation to Androgen Deprivation Therapy (ADT) monotherapy, achieved by completely discontinuing Androgen Receptor Pathway Inhibitor (ARPI) treatment (and associated corticosteroids). This de-escalation is initiated only after patients complete a 6-to-7-month run-in phase of standard doublet or triplet therapy.
Continuation of initial Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) combination therapy at standard dosesDrug
Arm-A serves as the standard-of-care control arm, in which patients continue their intensified combination therapy despite having achieved a deep clinical and molecular response. The intervention strictly involves continuing the identical Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) regimen-such as abiraterone, enzalutamide, apalutamide, or darolutamide-administered during the 6-to-7-month run-in phase, maintained at original doses.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Continuation | Active comparator | Patients continue the same ADT and ARPI that were administered during the run-in phase, at the same doses, until radiographic progression, unacceptable toxicity, death, withdrawal of consent, or end of assessment. Docetaxel will have been completed by month 6 and is therefore not continued. Receives: Drug: Continuation of initial Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) combination therapy at standard doses |
| Arm B - De-escalation | Experimental | Patients discontinue the ARPI (and any corticosteroid associated with abiraterone) at the randomization visit. ADT is continued uninterrupted at the same schedule as during the run-in phase. No other systemic anti-cancer therapy is administered unless progression is documented. Receives: Other: De-escalation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
18-month radiographic progression-free survival (rPFS)
Time from randomization to the earliest of: radiographic progression per PCWG4 on PSMA PET; unequivocal progression on PSMA PET (≥ 2 new lesions or PPP progression); or death from any cause. Patients without an event at 18 months are censored at last assessment.
Measured: Assessed from the date of randomization up to 18 months, with routine PSMA PET/CT imaging conducted every 6 months (patients without an event at 18 months are censored at their last assessment)
PSA progression-free survival
Time from randomization to confirmed PSA progression per PCWG4 (≥ 25 % rise and ≥ 2 ng/mL above nadir, confirmed ≥ 3 weeks later), or death
Measured: Assessed from the time of randomization until confirmed PSA progression or death, evaluated every 3 months for the first 24 months and every 6 months thereafter, through the total follow-up period (minimum 24 months post-randomization; up to 60 months)
Secondary outcomes (5)
Time to CRPC
Time from randomization to castration resistance per EAU/PCWG4 definition
Measured: Through study completion, an average of 5 years
Overall survival
Time from randomization to death from any cause
Measured: Assessed continuously from the date of randomization until death from any cause, with survival follow-up conducted every 6 months until study conclusion (up to approximately 60 months total duration)
PSMA PET complete response
Proportion with sustained PSMA PET complete response per modified PPP/RECIP at 12 and 24 months
Measured: From randomization, at 12 and 24 months
Change in Quality of Life Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Change from baseline in health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 includes a Global Health Status/Quality of Life (GHS/QoL) scale, functional scales, and symptom scales/items. All scales and single items range from 0 to 100. For the Global Health Status and functional scales, a higher score represents a higher/better level of functioning and quality of life. For symptom scales and items, a higher score represents a higher/worse level of symptoms or problems.
Measured: Assessed via changes from baseline, measured at screening, at the 6-7 month re-staging/randomization visit, and every 3 months post-randomization for the first 24 months
Incidence of Toxicity
Incidence of grade ≥3 AEs per CTCAE (Common Terminology Criteria for Adverse Events) v5.0
Measured: Monitored continuously and evaluated at every scheduled visit (every 3 months during the 6-7 month run-in phase, every 3 months for the first 24 months post-randomization, and every 6 months (up to 60 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration Sensitive 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. TB Yuvaraja, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838753
- Sponsor's protocol ID
- 040/2026
- Other IDs
- CTRI/2026/09/117118
- Acronym
- STEPDOWNmHSPC
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 7 Oct 2026
- 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2 Assessment of De-escalation to Androgen Deprivation Therapy Alone Versus Continuation of Doublet or Triplet Therapy in Responders With Metastatic Hormone-Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT07838753
- Acronym / sponsor ID
- STEPDOWNmHSPC / 040/2026
- Keywords
- Androgen Antagonists, Prostate-Specific Antigen, Metastatic Hormone-Sensitive Prostate Cancer, Androgen Deprivation Therapy, Androgen Receptor Pathway Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Kokilaben Dhirubhai Ambani Hospital and Medical Research InstituteUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 24 Sep 2026 (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 randomized comparative study (a study where participants are placed into groups by chance) is to find out if reducing treatment to androgen deprivation therapy (ADT)-a treatment that lowers testosterone-by itself works just as well as continuing the original combination of drugs. This study involves adult men with metastatic hormone-sensitive prostate cancer (prostate cancer that has spread to other parts of the body but still responds to hormone treatments) who have responded very well after 6 to 7 months of their initial two-drug or three-drug treatment.
The main questions it aims to answer are:
- Does reducing treatment to ADT alone work as well as the combination treatment at keeping the cancer from growing on imaging scans after 18 months, also known as radiographic progression-free survival (rPFS)?
- Does reducing treatment to ADT alone work as well as the combination treatment at preventing a rise in prostate-specific antigen (PSA), known as PSA progression-free survival (PSA-PFS)?
Researchers will compare a continuation group, which continues their initial two-drug or three-drug treatment, to a reduced-treatment group, which stops taking the androgen receptor pathway inhibitor (ARPI)-a drug that blocks the effects of hormones on cancer cells. Researchers want to see if reducing the treatment safely controls the cancer while lowering drug side effects and financial costs.
Participants will:
- Complete a 6- to 7-month initial period receiving a two-drug or three-drug treatment chosen by their doctor.
- Have blood tests for PSA and testosterone, and undergo a specialized imaging scan called a prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) scan, to confirm the treatment is working very well before being assigned to a study group.
- Stop taking the ARPI drug if assigned to the reduced-treatment group, or continue their current medications if assigned to the continuation group.
- Go to check-up visits every 3 months for the first 24 months to complete physical exams, blood tests, and quality-of-life surveys.
- Have a PSMA PET/CT scan every 6 months after being put into a group to check if the cancer has grown.
Detailed description
This phase 2 randomized comparative study investigates the de-escalation of systemic therapy for patients with metastatic hormone-sensitive prostate cancer (mHSPC) (STEPDOWNmHSPC i.e. Strategy for Therapy Escalation Pruning in metastatic Hormone Sensitive Prostate Cancer)who have achieved an optimal response to initial treatment.
- Background and Rationale:
In India, 40-60% of patients diagnosed with prostate cancer present with metastatic disease, a significantly higher rate than the 5-10% observed in Western cohorts. While indefinite doublet or triplet therapies (combining androgen deprivation therapy [ADT], androgen receptor pathway inhibitors [ARPI], and sometimes docetaxel) are the standard of care, they cause substantial cumulative physical, metabolic, and financial toxicities. Because a significant sub-population of patients achieves a deep response to these therapies, this trial evaluates whether carefully selected patients can safely de-escalate to ADT monotherapy without compromising oncological outcomes.
- Study Objectives:
- Primary Objective: To determine if de-escalation to ADT monotherapy is non-inferior to continuing doublet or triplet therapy regarding 18-month radiographic progression-free survival (rPFS) and PSA Progression-Free Survival (PSA-PFS).
- Secondary Objectives: To compare overall survival, time to castration-resistant prostate cancer (CRPC), sustained complete PSMA PET responses at 12 and 24 months, quality of life (using EORTC QLQ-C30 i.e. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30), incidence of severe adverse events, and economic burden between the two arms.
- Study Design and Methodology:
- Target Population: Adult men with histologically confirmed prostate adenocarcinoma, an ECOG (Eastern Co-operative Oncology Group) performance status of 0-2, and documented metastatic disease on PSMA PET/CT.
- Run-In Phase: The study will initially enrol approximately 265 patients, who will undergo 6 to 7 months of standard doublet or triplet therapy.
- Randomization: Following the run-in phase, patients who achieve an "optimal response"-defined as a serum PSA < 0.2 ng/mL, castrate testosterone levels (< 50 ng/dL), and a partial or complete response on PSMA PET/CT with no new lesions-will be randomized 1:1 into two arms. The trial targets 170 randomized patients (85 per arm) to account for an estimated 10% attrition rate.
Arm A (Continuation): Patients will continue their initial ADT and ARPI regimen at the same doses.
Arm B (De-escalation): Patients will discontinue the ARPI and continue with ADT monotherapy.
- Statistical Analysis:
To establish non-inferiority, the study utilizes a 15% margin with 80% power and a one-sided alpha of 0.10. Radiographic progression-free survival will be estimated using the Kaplan-Meier method, and treatments will be compared using a stratified log-rank test and Cox proportional hazards regression based on randomization stratification factors. The primary analysis will be performed on both the Intention-To-Treat (ITT) and Per-Protocol (PP) populations, requiring consistent findings in both to declare non-inferiority.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Continuation | Active comparator | Drug: Continuation of initial Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) combination therapy at standard dosesPatients continue the same ADT and ARPI that were administered during the run-in phase, at the same doses, until radiographic progression, unacceptable toxicity, death, withdrawal of consent, or end of assessment. Docetaxel will have been completed by month 6 and is therefore not continued. |
| Arm B - De-escalation | Experimental | Other: De-escalation strategyPatients discontinue the ARPI (and any corticosteroid associated with abiraterone) at the randomization visit. ADT is continued uninterrupted at the same schedule as during the run-in phase. No other systemic anti-cancer therapy is administered unless progression is documented. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- All patients of age group 18 to 80 years will be included
- Patients who would voluntarily agree to sign informed consent form
- Histologically confirmed adenocarcinoma of the prostate
- Evidence of metastatic disease at diagnosis (de novo) or after definitive local therapy, documented on PSMA PET/CT
- Intended to receive ADT plus an ARPI (abiraterone, enzalutamide, apalutamide or darolutamide) OR ADT plus ARPI plus docetaxel, as determined by the treating physician prior to enrolment
Key exclusion criteria (15 listed)
- Known small-cell, neuroendocrine or predominantly sarcomatoid histology
- Prior systemic therapy for prostate cancer other than ≤ 90 days of ADT (± a short course of first-generation anti-androgen for flare prevention) at enrolment
- Prior treatment with any ARPI, docetaxel, cabazitaxel, Ra-223 or 177Lu-PSMA
- Uncontrolled hypertension (systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg despite therapy), history of seizures or predisposing conditions (for enzalutamide candidates), unstable cardiac disease, recent myocardial infarction or stroke within 6 months
- Known active second malignancy requiring systemic therapy (except adequately treated non-melanoma skin cancer)
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 |
|---|---|---|
| De-escalation strategyThe experimental intervention is a response-adapted de-escalation to Androgen Deprivation Therapy (ADT) monotherapy, achieved by completely discontinuing Androgen Receptor Pathway Inhibitor (ARPI) treatment (and associated corticosteroids). This de-escalation is initiated only after patients complete a 6-to-7-month run-in phase of standard doublet or triplet therapy. | Other | Arm B - De-escalation |
| Continuation of initial Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) combination therapy at standard dosesArm-A serves as the standard-of-care control arm, in which patients continue their intensified combination therapy despite having achieved a deep clinical and molecular response. The intervention strictly involves continuing the identical Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) regimen-such as abiraterone, enzalutamide, apalutamide, or darolutamide-administered during the 6-to-7-month run-in phase, maintained at original doses. | Drug | Arm A - Continuation |
Primary outcome
18-month radiographic progression-free survival (rPFS)
Time frame: Assessed from the date of randomization up to 18 months, with routine PSMA PET/CT imaging conducted every 6 months (patients without an event at 18 months are censored at their last assessment)
Time from randomization to the earliest of: radiographic progression per PCWG4 on PSMA PET; unequivocal progression on PSMA PET (≥ 2 new lesions or PPP progression); or death from any cause. Patients without an event at 18 months are censored at last assessment.
PSA progression-free survival
Time frame: Assessed from the time of randomization until confirmed PSA progression or death, evaluated every 3 months for the first 24 months and every 6 months thereafter, through the total follow-up period (minimum 24 months post-randomization; up to 60 months)
Time from randomization to confirmed PSA progression per PCWG4 (≥ 25 % rise and ≥ 2 ng/mL above nadir, confirmed ≥ 3 weeks later), or death
5 secondary outcomes
Time to CRPC
Time frame: Through study completion, an average of 5 years
Overall survival
Time frame: Assessed continuously from the date of randomization until death from any cause, with survival follow-up conducted every 6 months until study conclusion (up to approximately 60 months total duration)
PSMA PET complete response
Time frame: From randomization, at 12 and 24 months
Change in Quality of Life Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Assessed via changes from baseline, measured at screening, at the 6-7 month re-staging/randomization visit, and every 3 months post-randomization for the first 24 months
Incidence of Toxicity
Time frame: Monitored continuously and evaluated at every scheduled visit (every 3 months during the 6-7 month run-in phase, every 3 months for the first 24 months post-randomization, and every 6 months (up to 60 months)
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 7 Oct 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 2 study testing De-escalation strategy and Continuation of initial Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) combination therapy at standard doses in people with Castration Sensitive Prostate Cancer and Metastatic Prostate Cancer, run by Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute at 1 site in India.
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 16 inclusion and 15 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: opening soon, as of the sponsor's last update on 7 Oct 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 India. 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?
Contact Thyavihally B. Yuvaraja, MBBS, MS, MCh, DNB (Urology) (+919321322505, tb.yuvaraja@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18-month radiographic progression-free survival (rPFS) (time frame: Assessed from the date of randomization up to 18 months, with routine PSMA PET/CT imaging conducted every 6 months (patients without an event at 18 months are censored at their last assessment)). 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 7 Oct 2026.