Prostate CarcinomaPhase 2RELAXNCT06818682
Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Trial
A Phase 2 study testing ADT for 9 months and ARTA for 6 months and ADT for 2 years in people with Prostate Carcinoma, run by Tata Memorial Centre at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- ADT for 9 months and ARTA for 6 months and ADT for 2 years
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteIndia
- Study dates
- 17 Feb 2025to 1 Jan 2035
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Centre
Mumbai, Maharashtra, 400012
Dr.Vedang Murthy, 02224176227, vedangmurthy@gmail.com
About this study
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.
- Conditions
- Prostate Carcinoma
- Being tested
- ADT for 9 months and ARTA for 6 months, ADT for 2 years
- Keywords
- Prostate Cancer, Prostate Radiotherapy, Hormone therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADT for 9 months and ARTA for 6 monthsDrug
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 yearsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | 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 Receives: Drug: ADT for 9 months and ARTA for 6 months |
| Standard Arm | Active comparator | 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 Receives: Drug: ADT for 2 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS), defined as the time to first clinicoradiological recurrence or death due to any cause, from the date of randomisation.
Measured: 5 years
Secondary outcomes (1)
Biochemical failure free survival (BFFS)
Time to biochemical failure (nadir PSA + 2ng/mL) or death due to any cause
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start17 Feb 2025
- Primary completion1 Jan 2035 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Vedang Murthy, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818682
- Sponsor's protocol ID
- 901060
- Acronym
- RELAX
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: May be shared request of PI
Publications
Murthy V, Maitre P, Priya S, Dhingra S, Dhanawat A, Shah M, Bhattacharya K, Adepu A, Singh P, Phurailatpam R, Patil D, Noronha V, Prabhash K, Misra A, Arora A, Pal M, Prakash G, Menon S, Joshi A. Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Controlled Trial. Clin Oncol (R Coll Radiol). 2026 Jun 27;57:104280. doi: 10.1016/j.clon.2026.104280. Online ahead of print.
PubMed 42567090
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Trial
- ClinicalTrials.gov ID
- NCT06818682
- Acronym / sponsor ID
- RELAX / 901060
- Conditions
- Prostate Carcinoma
- Keywords
- Prostate Cancer, Prostate Radiotherapy, Hormone therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 1 Jan 2035 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Drug: ADT for 9 months and ARTA for 6 monthsRadiotherapy 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 |
| Standard Arm | Active comparator | Drug: ADT for 2 yearsRadiotherapy 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 |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADT for 9 months and ARTA for 6 monthsRadiotherapy 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 | Drug | Test Arm |
| ADT for 2 yearsRadiotherapy 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 | Drug | Standard Arm |
Primary outcome
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
1 secondary outcome
Biochemical failure free survival (BFFS)
Time frame: 5-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Derived from this study: PubMed 42567090Murthy V, Maitre P, Priya S, Dhingra S, Dhanawat A, Shah M, Bhattacharya K, Adepu A, Singh P, Phurailatpam R, Patil D, Noronha V, Prabhash K, Misra A, Arora A, Pal M, Prakash G, Menon S, Joshi A. Reduced Length of ADT and ARTA With XRT in High-Risk Prostate Cancer (RELAX): A Randomised Controlled Trial. Clin Oncol (R Coll Radiol). 2026 Jun 27;57:104280. doi: 10.1016/j.clon.2026.104280. Online ahead of print.
- Individual participant dataSharing planned: No. May be shared request of PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADT for 9 months and ARTA for 6 months and ADT for 2 years in people with Prostate Carcinoma, run by Tata Memorial Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06818682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.