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NCT Number: NCT06818682

Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Trial

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.

Recruiting

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

19 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADT for 9 months and ARTA for 6 months

Drug

Radiotherapy to prostate and pelvic nodes (66-68Gy and 50Gy in 25 fractions OR 60-62Gy and 44Gy in 20 fractions OR 36.25-40Gy and 25Gy in 5 fractions) with ADT for 9 months and ARTA for 6 months

ADT for 2 years

Drug

Radiotherapy to prostate and pelvic nodes (66-68Gy and 50Gy in 25 fractions OR 60-62Gy and 44Gy in 20 fractions OR 36.25-40Gy and 25Gy in 5 fractions) with ADT for 2 years

Primary outcomes

  1. Disease-free survival (DFS), defined as the time to first clinicoradiological recurrence or death due to any cause, from the date of randomisation.

    Time frame: 5 years

Secondary outcomes

  1. Biochemical failure free survival (BFFS)

    Time frame: 5-year

    Time to biochemical failure (nadir PSA + 2ng/mL) or death due to any cause

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Tata Memorial Centre

Other

Registry information

Acronym: RELAX

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Feb 10, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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