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New treatment option for Prostate Carcinoma
Official title Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Trial
ClinicalTrials.gov ID: NCT06818682
What this study is testing
What is ADT for 9 months and ARTA for 6 months?
ADT for 9 months and ARTA for 6 months is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for prostate carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 99, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Mumbai, Maharashtra, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 19 years to 99 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mumbai, Maharashtra, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.