Observational study on radiation therapy and hormone treatment for high-risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the effectiveness of Stereotactic Body Radiation Therapy (SBRT) combined with Androgen Deprivation Therapy (ADT) in patients with organ-confined high-risk prostate cancer. It aims to evaluate the outcomes of this treatment approach, particularly focusing on disease control and toxicity levels compared to conventional radiation therapy. Eligible participants include men over 18 years with specific high-risk factors for prostate cancer, and the study will monitor their responses to the treatment over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \> 18 years
* ECOG performance status ≤ 2
* Histologically proven prostate adenocarcinoma
* High-risk group classification according to National Comprehensive Cancer Network (NCCN), defined by the presence of any one of the following high-risk factors: cT3-cT4 OR Grade Group 4 or Grade Group 5 OR PSA \>20 ng/mL
* No pelvic nodal and distant metastases at staging with PSMA-PET
* IPSS ≤ 15 (alpha blockers allowed)
* Life expectancy of \> 5 years
* Prostate volume ≤ 100 cc

Exclusion Criteria:

* Previous local radiation treatment of the prostate
* Previous radiotherapy to the pelvis
* Active Ulcerative Colitis or Crohn's Disease
* Previous tumors unless disease free for a minimum of 5 years

Where it's running

• IRCCS Humanitas Research Hospital
  Rozzano, Milan, Italy Recruiting
• Humanitas Gavazzeni
  Bergamo, Bergamo, Italy Not yet recruiting
• Humanitas PIO X
  Milan, Milan, Italy Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Radiation therapy options for high-risk prostate cancer

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• Repeated PSMA PET scans to monitor treatment response in clinically significant prostate cancer.

  This project will test whether doing a PSMA PET/CT before treatment and again after treatment (or at early PSA rise) helps track response in people with newly diagnosed clinically significant (Gleason ≥7) prostate cancer.

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• Androgen-guided PSMA-PET-boost for prostate cancer treated with ADT and SBRT

  This study tests whether using PSMA-PET imaging during hormone therapy can help doctors target remaining cancer with a focused SBRT boost in men with intermediate- or high-risk prostate cancer.

  Recruiting at 2 sites Phase 2 Brigham and Women's Hospital · Boston, Massachusetts and 3 other locations · NCT07393867

• Delayed pelvic [68Ga]-PSMA PET/CT using the first CT for men with high-risk prostate cancer

  This test tries to see if doing a delayed pelvic [68Ga]-PSMA PET that reuses the initial CT (so no second CT) keeps image quality while lowering radiation for men with high‑risk or recurrent prostate cancer.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, Italy · NCT07357259

• Tb-PSMA radionuclide treatment before radical prostatectomy for locally advanced prostate cancer

  This will try giving a Tb-PSMA radionuclide treatment to men with high-risk, locally advanced prostate cancer before prostate removal to see if it is safe and reduces tumor burden.

  Recruiting Phase 1/2 Rabin Medical Center · Petah Tikva · NCT07208240

• Adaptive stereotactic body radiotherapy with pelvic treatment and focal dose boost for high-risk prostate cancer

  This trial will try an adaptive form of focused high-dose radiation to the prostate and pelvic lymph nodes, with an extra dose to the main tumor area, for men with high-risk prostate cancer to see if it improves outcomes and cost-effectiveness compared with standard radiotherapy.

  Recruiting Center Eugene Marquis · Rennes · NCT07189598

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.