NCT07838753Toborzás még nem indult2. fázis

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

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 7.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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: 1. 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)? 2. 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: 1. Complete a 6- to 7-month initial period receiving a two-drug or three-drug treatment chosen by their doctor. 2. 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. 3. Stop taking the ARPI drug if assigned to the reduced-treatment group, or continue their current medications if assigned to the continuation group. 4. Go to check-up visits every 3 months for the first 24 months to complete physical exams, blood tests, and quality-of-life surveys. 5. Have a PSMA PET/CT scan every 6 months after being put into a group to check if the cancer has grown.

Állapot (regiszter): Toborzás még nem indult
Fázis (regiszter): 2. fázis
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 170 (tervezett)
Első benyújtás: 2026. szept. 14.
Kezdés: 2026. szept.
Elsődleges befejezés: 2029. szept.
Fő szponzor: Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
Betegségek: Prosztatarák
NCT-szám: NCT07838753

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó · 2. fázis
Tervezett résztvevők: 170
2026. szept. és az elsődleges befejezés (2029. szept.) között
1 helyszín, 1 országban
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Korábbi kezelés

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
Grade ≥ 3 ongoing toxicities attributable to current therapy that precludes continuation

Más betegség

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
Psychiatric or cognitive disorder limiting capacity to consent or comply with protocol
Development of symptomatic disease (e.g. new bone pain requiring opioid therapy, cord compression, pathological fracture)

Laborértékek

Serum PSA ≥ 0.2 ng/mL or any PSA rise above nadir of ≥ 25 %

Egyéb

Known small-cell, neuroendocrine or predominantly sarcomatoid histology
Any contraindication to the chosen ARPI, docetaxel or ADT per respective product labels
Any new lesion on PSMA PET or conventional imaging
Progression at existing sites per PCWG4 or PPP
Testosterone ≥ 50 ng/dL (non-castrate)
Withdrawal of consent

Kiket keres a vizsgálat

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
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

Életkor a regiszterben: 18 év – 80 év · Nem: csak férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute	Mumbai	India	Ismeretlen állapot

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