Printed from Voxsanity (voxsanity.com.au) — NCT06758882 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Prostate Cancer
Phase 2 Prostate Cancer Trial, Recruiting
NCT06758882
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:
- You are between 18 and 79 years old
- You have signed a consent form showing you understand and agree to take part in the study
- Your prostate cancer has been confirmed by a tissue biopsy as a type called adenocarcinoma
- Your cancer is considered high-risk, with a Gleason score of 8 or higher (Grade Group 4 or 5)
- Standard scans (CT or bone scan) have not shown cancer spread to other parts of your body
- A special type of scan called a PSMA PET/CT, done before surgery, shows a limited amount of cancer spread (low volume metastatic disease) (confirm with trial site)
- You are considered suitable for prostate removal surgery with lymph node removal
- You are generally well enough to carry out daily activities with little or no limitation (ECOG score of 0 or 1)
- Your liver, kidneys, and blood counts are within acceptable ranges based on blood tests
- You are able to receive hormone-blocking therapy for at least 18 months, based on your heart health assessment
- You are able to swallow tablets whole
Who may not be able to join:
- Standard scans show your cancer has spread to distant parts of the body (though lymph node involvement in the pelvis area does not automatically rule you out)
- You have already received hormone therapy for prostate cancer (such as GnRH drugs)
- You have had both testicles surgically removed
- You have had any previous treatment for prostate cancer, including radiation or other local treatments
- You have taken part in another clinical trial or received any prostate cancer treatment within 4 weeks before your planned surgery
- You have had major surgery within 4 weeks before your planned surgery
- You have had a serious heart or blood vessel problem in the past 12 months, such as a heart attack, unstable chest pain, stroke, blood clot in the lungs, or significant heart failure (confirm with trial site)
- You are HIV-positive and meet certain conditions related to your HIV treatment or health status, or you have active hepatitis or chronic liver disease (confirm with trial site)
- You have a history of seizures, stroke, loss of consciousness within the past year, or certain brain conditions (confirm with trial site)
- You are currently taking certain medications that are not allowed in this trial, including some that affect heart rhythm or lower the seizure threshold (confirm with trial site)
- You have a stomach or bowel condition that affects how your body absorbs medication
- You are known to be allergic or have a medical reason not to take apalutamide or hormone-blocking therapy
- Your doctor feels that taking part in the trial would not be in your best interest
- You have another active cancer that has been progressing or needed treatment in the last 24 months (some exceptions may apply, such as certain skin cancers or breast conditions — confirm with trial site)
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.
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.
Contact this trial
Phone: 00390116707682
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Phase 2
Sponsor
Marco Oderda
Registry
ClinicalTrials.gov
Start date
25 November 2024
Est. completion
1 January 2026
Where this trial is recruiting
🇮🇹 Italy
Primary endpoints
Radiological progression-free survival (RPFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 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.