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NCT Number: NCT05884632

Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients

This is a monoinstitutional prospective pilot study, aiming to evaluate treatment-related toxicity of an hypofractionated postoperative salvage radiotherapy with daily-adaptive modality in patients affected by prostate cancer biochemical recurrence.

Patients will be treated with postoperative hypofractionated salvage radiotherapy with a dose of 59 Gy in 20 fractions with daily-adaptive modality. Considering the consolidate role and clinical outcome of postoperative hypofractionated radiotherapy with elevate level of evidence (8-10), the study will not be controlled, but compared with literature data.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, 37024, Italy

Location status: Recruiting

Location contact

Luca Nicosia, Doctor

CONTACT

[email protected]

+39(0)456014800

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≤ 80 years;
  • Prostate cancer diagnosis, pT2-3 pN0, any resection margin (R0 or R1);
  • Indication to local salvage treatment defined as: early salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA <0.2 ng/ml or salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA ≥0.2 ng/ml;
  • No distant metastases (M0) diagnosed with PSMA-PET-CT;
  • Informed consent to trial's participation and personal data treatment.

Exclusion criteria

  • Age <18 years old;
  • Adjuvant radiotherapy;
  • Previous radiation in the same anatomical site.

Treatment and study plan

Daily Adaptive RadioTherapy

Radiation

Patients will be treated on the prostate bed with Ethos using daily-adaptive modality with the dose of 59 Gy in 20 daily fractions of 2.95 Gy

Primary outcomes

  1. Acute gastrointestinal toxicity

    Time frame: 90 days from the RT treatment

    Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any gastrointestinal event occurred within 90 days from the RT treatment with grade ≥G2.

Secondary outcomes

  1. Acute genitourinary toxicity

    Time frame: 90 days from the RT treatment.

    Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any genitourinary event occurred within 90 days from the RT treatment.

  2. Late toxicity

    Time frame: From 90 days after the RT treatment until 24 months

    Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, late toxicity will be defined as any event (genitourinary and gastrointestinal) occurred from 90 days after the RT treatment.

  3. QLQ-C30

    Time frame: At screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months

    Patient-reported outcomes will be assessed via the EORTC global (QLQ-C30) questionnaires at screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months

  4. Biochemical failure

    Time frame: 24 months

    PSA raise after RT from nadir

  5. Time to biochemical failure

    Time frame: 24 months

    Time between salvage RT and biochemical failure

  6. Local in-field relapse

    Time frame: 24 months

    Local in-field relapse evaluated with PET-CT or RM

  7. Metastases-free survival

    Time frame: 24 months

    Metastases-free survival evaluated with PSMA PET-TC in case of PSA raise

Study contacts

Contact information is provided by the study sponsor or research team.

Elvia Malo

CONTACT

[email protected]

+390456014854

Sponsors and collaborators

Lead sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Other

Registry information

Acronym: DART-PHASER

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jun 1, 2023
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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