Clinical trial NCT06818682: Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Trial
Official title: Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Carcinoma
Keywords: Prostate Cancer
Prostate Radiotherapy
Hormone therapy
Lead sponsor: Tata Memorial Centre
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 206
Sex: MALE
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study to improve the treatment of high-risk non-metastatic prostate cancer by comparing reduced duration of hormone therapy to the standard duration of two years, when combined with curative intent standard of care radiotherapy to prostate and pelvic nodes. The reduced duration will be intensified with addition of newer hormonal agents such as abiraterone or enzalutamide tablets, which have been shown to improve disease control in locally advanced prostate cancer. This is hoped to reduce the side effects of prolonged hormone therapy, while maintaining similar rates of disease control and survival.

The effectiveness of both treatment approaches will be assessed in terms of cancer control, survival, and overall quality of life of patients. Additionally, the study will examine the side effects associated with each treatment regimen, which could provide valuable insights into impact of treatment duration on patients. If a person decides not to participate, they will still receive the standard two years of hormonal therapy and radiation therapy outside the study. This ensures that all patients receive appropriate care regardless of their involvement in the research. Participation is voluntary, and will not affect patient care.


Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival (DFS), defined as the time to first clinicoradiological recurrence or death due to any cause, from the date of randomisation.
timeFrame: 5 years
Secondary outcomes:
measure: Biochemical failure free survival (BFFS)
timeFrame: 5-year
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial Centre
state: Maharashtra
Study officials:
References: