Phase 3 Prostate Cancer Trial, Recruiting NCT05946213 Sponsor: NRG Oncology Condition: Prostate Cancer
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Phase 3 Prostate Cancer Trial, Recruiting

NCT05946213
Recruiting Phase 3

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 adenocarcinoma (a specific type of prostate cancer) confirmed by a tissue or cell sample from a biopsy
  • People whose cancer is considered "high-risk" based on at least one of the following: the tumour has grown to a certain size or beyond the prostate based on physical exam or imaging (but not spread to nearby organs); a PSA blood test result above 20 ng/mL before starting hormone therapy; a Gleason score (a measure of how aggressive the cancer looks under a microscope) of 8, 9, or 10; or lymph nodes in the pelvis that appear affected on standard imaging
  • People whose prostate gland measured less than 100 cc (a measure of size) before starting hormone therapy, based on biopsy records or imaging such as ultrasound, MRI, or CT scan
  • People with no clear signs on standard imaging (bone scan, CT, or MRI) that the cancer has spread beyond the pelvic lymph nodes — a type of specialised scan called a PSMA PET scan showing no spread is also acceptable
  • People aged 18 or older
  • People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities with little to no limitation) (confirm with trial site)
  • People who have not previously had radiation therapy to the prostate area that would overlap with the treatment fields used in this trial
  • People who have not previously had surgical removal of the prostate (radical prostatectomy)
  • People who have not previously had any ablative or targeted treatments to the prostate, such as HIFU, laser ablation, cryotherapy, or similar procedures
  • People who may have already started hormone therapy (androgen deprivation therapy), provided it began no more than 185 days before registering for the trial
  • People who are able to have a prostate MRI scan (required for treatment planning in this trial)
  • People who are also enrolled in a related study called NRG-GU013 before radiation treatment planning begins

Who may not be able to join:

  • People whose cancer has spread beyond the pelvic lymph nodes to other parts of the body, such as distant lymph nodes, bones, or other organs, based on standard imaging
  • People whose tumour has been assessed as cT4 (meaning it has grown into nearby organs) on physical exam or imaging
  • People who have previously had radiation therapy to the prostate area in a way that would overlap with the radiation fields used in this trial
  • People who have previously had the prostate surgically removed
  • People who have previously had any ablative or focal treatments to the prostate (such as HIFU, laser ablation, cryotherapy, irreversible electroporation, or photodynamic therapy)
  • People who started hormone therapy more than 185 days before registering for the trial
  • People who are unable to have an MRI scan of the prostate
  • People whose prostate gland was 100 cc or larger before starting hormone therapy
  • People who are not enrolled in the related NRG-GU013 study prior to the start of radiation treatment planning

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 19 July 2026
Phase 3: approximately ~65% 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 3
Sponsor
NRG Oncology
Registry
ClinicalTrials.gov
Start date
14 December 2023
Est. completion
31 March 2036

Where this trial is recruiting

🇨🇦 Canada Hong Kong 🇨🇭 Switzerland 🇺🇸 United States

Primary endpoints

Metastasis-free survival (MFS)

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: 19 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