Shorter hormone therapy combined with radiotherapy for high-risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to improve treatment outcomes for high-risk non-metastatic prostate cancer by comparing a reduced duration of hormone therapy to the standard two-year duration, alongside standard radiotherapy. The shorter hormone therapy will be intensified with newer agents like abiraterone or enzalutamide, which have shown promise in enhancing disease control. The study will evaluate cancer control, survival rates, and overall quality of life, while also assessing the side effects associated with each treatment regimen. This approach seeks to minimize the side effects of prolonged hormone therapy without compromising treatment efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:-

* Patients with biopsy proven prostate adenocarcinoma, deemed suitable for curative- intent radiotherapy
* Clinicoradiological stage T1-T4N0M0 using PSMA-PETCT and MRI
* High risk or very high risk (as per NCCN 2023): stage T3a + OR Gleason Score 4+4 or 4+5 OR PSA 20 +
* Patient fit and able to receive ADT for 2 years
* Patient fit and able to receive ARTA for 6 months
* ECOG performance status 0-2
* Patient able and willing for informed consent and reliable for follow-up

Exclusion Criteria:-

* Primary Gleason pattern 5 (Gleason score 5+4 or 5+5)
* Life expectancy deemed to be less than 2 years
* Uncontrolled comorbidities such as diabetes or hypertension causing ineligibility to receive ARTA
* Bulky primary disease with extensive infiltration into bladder/rectum/pelvic muscle
* Prior ADT more than 3 months before screening or prior orchiectomy
* Prior prostatectomy
* Unsuitable for curative dose of radiotherapy (severe urinary obstructive symptoms, inflammatory bowel disease, prior pelvic radiotherapy etc.)
* Presence of adverse pathological variants (such as small cell histology)
* Unable or unwilling to consent and follow up

Where it's running

• Tata Memorial Centre
  Mumbai, Maharashtra, India Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.