Personalized Treatment for Advanced Prostate Cancer Using Genetic Risk (MAP-PROSTATE Study)

Molecular risk adapted treatment modification in patients with metastatic hormone sensitive prostate cancer. (MAP-PROSTATE). - Prostate Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090975

Enrollment

314

Registered

2025-07-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C61- Malignant neoplasm of prostate

Interventions

Intervention1: Cohort A- Docetaxel,Cabazitaxel,Carboplatin,Cisplatin: Docetaxel will be administered as per the standard institutional practice (50 mg/m2 2-weekly for up to 9 cycles, or 75 mg/m2 3-wee

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed,De novo or recurrent patients with metastatic hormone sensitive prostate cancer 2. Completed 18 years of age 3. ECOG-PS 0-2 4. with adequate organ functions 5. controlled co-morbidities 6. willing to comply and consent to the study.

Exclusion criteria

Exclusion criteria: 1. Participants who are receiving any other investigational agents. 2. History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to any agents used in study. 3. Patients unfit for docetaxel or abiraterone or enzalutamide or apalutamide or PARPi based therapy. 4. Uncontrolled intercurrent illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, inflammatory bowel disease, known hyperkalaem.

Design outcomes

Primary

Measure	Time frame
To compare non-inferiority of treatment in Arm-A (biomarker driven treatment allocation), to treatment in Arm-B (biomarker blind, standard triplet therapy) to improve 3-year Overall Survival (OS) in patients with de-novo or recurrent metastatic hormone sensitive prostate cancerTimepoint: 3 years	—

Secondary

Measure	Time frame
1.PSA less than 0.2ng/ml at 7 months of treatment initiation. 2.To evaluate radiological progression free survival (rPFS). 3.To evaluate PSA progression free survival (PSA-PFS). 4.To compare the best overall response rate (ORR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. 5.To assess and compare safety and tolerability. 6.To compare the quality of life (QOL). 7.To evaluate time to pain progression. 8.To evaluate time-to-first symptomatic skeletal event (SSE). 9.To evaluate SSE-Free Survival (SSE-FS). Timepoint: 3 years	—

Measure

Time frame

1.PSA less than 0.2ng/ml at 7 months of treatment initiation. 2.To evaluate radiological progression free survival (rPFS). 3.To evaluate PSA progression free survival (PSA-PFS). 4.To compare the best overall response rate (ORR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. 5.To assess and compare safety and tolerability. 6.To compare the quality of life (QOL). 7.To evaluate time to pain progression. 8.To evaluate time-to-first symptomatic skeletal event (SSE). 9.To evaluate SSE-Free Survival (SSE-FS). Timepoint: 3 years

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Countries

India

Contacts

Public ContactDr Minit Shah

Tata Memorial Hospital

minitjshah@gmail.com9892640668

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026