ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY (AMPORA)

Phase 2

Recruiting

• Conditions: Post-Operative Prostate Cancer
• Interventions: Radiation: Radiotherapy

• Registration Number: NCT06409910
• Lead Sponsor: University Health Network, Toronto

Brief Summary

This is a multi-institution, randomized, non-inferiority Phase II trial comparing external beam radiotherapy delivered as 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily with external beam radiotherapy delivered as 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-05-07
• Study First Posted: 2024-05-10
• Study Start: 2024-11-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2030-11
• Study Completion: 2030-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 204

Inclusion Criteria

1. Age > 18 years
2. Able to provide informed consent
3. Histologic diagnosis of prostate adenocarcinoma
4. ECOG performance status 0-1
5. Previous radical prostatectomy > 6 months prior to radiotherapy start date
6. Planned to receive post-operative radiation

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Exclusion Criteria

1. Prior pelvic radiotherapy
2. Contraindications to radiotherapy
3. Mets confirmed as per (if scan has been done for clinical care)
4. Participants with visible disease in the prostate bed or pelvic lymph nodes on imaging are not eligible for treatment on study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Ultrahypofractionated Radiotherapy	Radiotherapy	External beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.
Arm 1: Moderately Hypofractionated Radiotherapy	Radiotherapy	External beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily.

Primary Outcome Measures

Name	Time	Method
Rates of Acute Toxicity	2 years	Acute grade ≥2 gastrointestinal toxicity (CTCAE v5.0)

Secondary Outcome Measures

Name	Time	Method
Biochemical disease-free survival	2 years	Defined as survival until evidence of either biochemical progression (defined as a rise in prostate-specific antigen (PSA) ≥0.2ng/ml above the PSA nadir followed by a sequentially equal or higher value) following postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol systemic therapy, or death from prostate cancer
Disease Control Rate	2 years	Radiographic and/or histopathological disease control rate
Rates of Acute and Late Toxicity	2 years	Acute grade ≥2 genitourinary toxicity (CTCAE v5.0)
Quality of Life Outcomes	2 years	IPSS Questionnaire

Trial Locations

Locations (1)

University Health Network - Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada