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DART-PHASER: Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients

Sponsor
IRCCS Sacro Cuore Don Calabria di Negrar (Other)
Overall Status
Recruiting
CT.gov ID
NCT05884632
Collaborator
(none)
184
Enrollment
1
Location
1
Arm
84.9
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Daily Adaptive RadioTherapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
184 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
Actual Study Start Date :
Apr 3, 2023
Anticipated Primary Completion Date :
Apr 30, 2030
Anticipated Study Completion Date :
Apr 30, 2030

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment arm

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

Radiation: Daily Adaptive RadioTherapy
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

Outcome Measures

Primary Outcome Measures

  1. Acute gastrointestinal toxicity [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 Outcome Measures

  1. Acute genitourinary toxicity [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 [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 [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 [24 months]

    PSA raise after RT from nadir

  5. Time to biochemical failure [24 months]

    Time between salvage RT and biochemical failure

  6. Local in-field relapse [24 months]

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

  7. Metastases-free survival [24 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Sacro Cuore Don Calabria di Negrar Negrar Verona Italy 37024

Sponsors and Collaborators

  • IRCCS Sacro Cuore Don Calabria di Negrar

Investigators

  • Principal Investigator: Luca Nicosia, IRCCS Sacro Cuore Don Calabria - Dipartimento di Radioterapia Oncologica Avanzata

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IRCCS Sacro Cuore Don Calabria di Negrar
ClinicalTrials.gov Identifier:
NCT05884632
Other Study ID Numbers:
  • 2022-51
First Posted:
Jun 1, 2023
Last Update Posted:
Jun 1, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jun 1, 2023