Actively Recruiting

Age: 18Years - 90Years
MALE
ID06941363

Salvage Ultrahypofractionated Postoperative External Radiotherapy for Biochemical Recurrence of Prostate Cancer

Led by University of Milano Bicocca · Updated on 2026-02-02

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new radiation therapy approach for men with prostate cancer who have biochemical recurrence or persistent detectable PSA after prostatectomy. This observational study focuses on the safety and toxicity profile of salvage single-fraction stereotactic radiotherapy (SDRT) delivered to the prostate bed using advanced image-guided volumetric intensity-modulated arc therapy (IGRT-VMAT). The study is designed to improve precision in radiation delivery while protecting surrounding organs. The treatment involves a single high-dose radiation session with doses escalated through three levels: 15 Gy, 16 Gy, and 17 Gy, delivered in one fraction. The study has two stages: an initial dose-escalation phase to find the maximum tolerated dose, followed by a dose-expansion phase enrolling up to 50 patients to evaluate safety across all dose levels. Androgen deprivation therapy may be used based on physician choice. Participants will undergo regular assessments including toxicity evaluations up to 5 years, quality of life questionnaires, and PSA testing to monitor biochemical relapse. Safety is closely monitored through acute and late adverse event tracking. The total participation includes follow-ups at 3 months, 1 year, 2 years, and 5 years to assess urinary symptoms, erectile function, and overall quality of life.

CONDITIONS

Brief Title

Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence

Who Can Participate

Age: 18Years - 90Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male sex aged 18 years or older
  • Signed informed consent before starting the study
  • Diagnosed with adenocarcinoma of the prostate treated with any type of radical prostatectomy
  • Detectable post-prostatectomy PSA between 0.1 and less than 2.0 ng/mL, either persistently detectable or developing biochemical recurrence
  • No evidence of lymph node or distant metastases based on PSMA PET-CT within 90 days before registration
  • Negative pelvic MRI if PSMA PET-CT findings are unclear for local relapse
  • Androgen deprivation therapy allowed as per physician's discretion
  • ECOG performance status of 0 or 1
  • Ability to complete study questionnaires
Not Eligible

You will not qualify if you...

  • Presence of lymph node (N1) or distant metastases (M1)
  • Macroscopic local relapse detected by pelvic MRI
  • Prior radiation therapy to the prostate gland or pelvis
  • Previous brachytherapy
  • History of inflammatory colitis or other active severe medical conditions
  • Current use of immunosuppressant medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day treatment with 90-day safety evaluation

Participants receive a single dose of salvage radiation therapy to the prostate bed using image-guided techniques.

1 treatment visit and multiple safety follow-up visits during 90 days

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for late treatment-related adverse events, quality of life, and biochemical relapse over several years.

Follow-up visits at 3 months, 1 year, 2 years, and 5 years

Trial Site Locations

Total: 1 location

1

Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori (University of Milan Bicocca)

Monza, Italy, Italy, 20900

Actively Recruiting

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Research Team

S

Stefano Arcangeli, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Quality-of-Life Outcomes and Toxicity Profile Among Patients With Localized Prostate Cancer After Radical Prostatectomy Treated With Stereotactic Body Radiation: The SCIMITAR Multicenter Phase 2 Trial.

Ting Martin Ma, Leslie K Ballas, Holly Wilhalme...

https://pubmed.ncbi.nlm.nih.gov/36007724

Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer.

Robert T Dess, Yilun Sun, William C Jackson...

https://pubmed.ncbi.nlm.nih.gov/32215583

Toxicity profile and Patient-Reported outcomes following salvage Stereotactic Ablative Radiation Therapy to the prostate Bed: The POPART multicentric prospective study.

Federica Ferrario, Ciro Franzese, Valeria Faccenda...

https://pubmed.ncbi.nlm.nih.gov/38111610

Acute Toxicity and Quality of Life in a Post-Prostatectomy Ablative Radiation Therapy (POPART) Multicentric Trial.

Raffaella Lucchini, Ciro Franzese, Suela Vukcaj...

https://pubmed.ncbi.nlm.nih.gov/36547147

Noninferiority of Hypofractionated vs Conventional Postprostatectomy Radiotherapy for Genitourinary and Gastrointestinal Symptoms: The NRG-GU003 Phase 3 Randomized Clinical Trial.

Mark K Buyyounouski, Stephanie L Pugh, Ronald C Chen...

https://pubmed.ncbi.nlm.nih.gov/38483412