Phase 2 Prostate Cancer Trial, Recruiting NCT06818682 Sponsor: Tata Memorial Centre Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06818682
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with prostate cancer confirmed by a tissue biopsy, and whose doctors consider them suitable for radiotherapy aimed at curing the cancer
  • People whose cancer has been assessed using specialist scans (PSMA-PET/CT and MRI) and found to be at a certain stage — present in the prostate area but not spread to lymph nodes or other parts of the body (stage T1–T4, N0, M0)
  • People whose cancer is classified as "high risk" or "very high risk" based on specific features: cancer that has grown beyond the prostate (stage T3a or higher), OR a Gleason score of 4+4, 4+5 (a measure of how aggressive the cancer looks under a microscope), OR a PSA level of 20 or above
  • People who are well enough to receive a hormone therapy called ADT for 2 years
  • People who are well enough to receive a type of hormone-blocking tablet (called an ARTA) for 6 months
  • People with a general health and activity level rated as ECOG 0–2 (confirm with trial site), meaning they are able to carry out daily activities with at most some limitations
  • People who are willing and able to give informed consent and attend follow-up appointments

Who may not be able to join:

  • People whose biopsy shows a primary Gleason pattern of 5 (Gleason score 5+4 or 5+5), indicating a more aggressive cancer pattern
  • People whose life expectancy is estimated to be less than 2 years
  • People with poorly controlled health conditions such as diabetes or high blood pressure that would make it unsafe to take the ARTA medication
  • People whose cancer has grown extensively into nearby organs such as the bladder, rectum, or pelvic muscles
  • People who have already received hormone therapy (ADT) for more than 3 months before the screening visit, or who have had surgical removal of the testicles (orchiectomy)
  • People who have previously had their prostate surgically removed (prostatectomy)
  • People who are not suitable for a full curative dose of radiotherapy — for example, due to severe urinary blockage symptoms, inflammatory bowel disease, or previous radiotherapy to the pelvic area
  • People whose biopsy shows an unusual or particularly aggressive cancer cell type (such as small cell histology)
  • People who are unwilling or unable to give consent or attend follow-up appointments

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Tata Memorial Centre
Registry
ClinicalTrials.gov
Start date
17 February 2025
Est. completion
1 January 2035

Where this trial is recruiting

🇮🇳 India

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov