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A comparison of androgen deprivation therapy alone versus in combination with additional treatments in patients with hormone-sensitive metastatic prostate cancer exploring their impact on cancer outcomes, quality of life, and treatment-related side effects.

Androgen deprivation therapy(ADT) vs. ADT with adjuvant therapy in hormone na ve metastatic CA prostate (mHNPC) patients and its effects on trifecta outcomes- oncological outcomes, health related quality of life (HRQoL) and side effect profile of ADT and adjuvant therapy. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/085915
Enrollment
50
Registered
2025-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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: Nil: Nil

Sponsors

Dr Padmaraj Hegde
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of metastatic hormone na ve carcinoma prostate

Exclusion criteria

Exclusion criteria: Patients with low-risk localised carcinoma prostate. Patients with locally advanced carcinoma prostate. Patients of CA prostate who have received prior ADT or hormonal therapy.

Design outcomes

Primary

MeasureTime frame
To study the PSA response and trend in patients with ADT vs ADT with adjuvant therapy. To study ADT vs ADT with adjuvant therapy in terms of effect on Side effect profile of hormonal deprivation. Cardiovascular health. Metabolic profile. Bone health.Timepoint: Cardiovascular and bone health parameters evaluated 6 monthly and the rest 3 monthly—

Secondary

MeasureTime frame
To study the patient compliance and tolerability to the treatment. To study the HRQoL in patients receiving ADT vs ADT with adjuvant therapy.Timepoint: Evaluated every 3 monthly—

Countries

India

Contacts

Public ContactAishwarya Avinash Tinaikar

Kasturba Medical College, Manipal

padmaraj.hegde@manipal.edu9900264579

Outcome results

None listed

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