A First Step Towards Ultra-hypofractionation for Unfavourable Intermediate and High-risk Prostate Cancer

NCT05361902 | Active Not Recruiting

• 1 other identifier: MEC-2021-0540
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to make a first step towards ultra-hypofractionation for high-risk prostate cancer by proving the technical feasibility of margin reduction of the seminal vesicles by combining the intra-fraction fiducial tracking with an online re-planning workflow for each fraction to account for the inter-fraction seminal vesicle motion.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; High Risk; Ultra-hypofractionation; Feasibility study

Outcome Measures

Primary Outcomes (1)

• Feasibility of margin reduction expressed as percentage of underdosage at the seminal vesicles

  Percentage of patients for which in 0 or 1 fraction out 6 fractions the seminal vesicles were underdosed. Underdosage being defined as 95% of the volume of SV receiving \< 95% of prescribed dose. In the case of unavoidable underdosage of the target on the reference plan, coverage below the achieved coverage in the reference plan will be seen as an underdosed fraction. The margin reduction of the SV is considered feasible when ≥90% of patients received successful treatments.

  17 months

Secondary Outcomes (4)

• Acute toxicity (RTOG/EORTC)

  20 months

• Acute toxicity (CTCAE)

  20 months

• Late toxicity (RTOG/EORTC)

  4 years

• Late toxicity (CTCAE)

  4 years

Study Arms (1)

Intervention Arm

EXPERIMENTAL

All included patients will be treated according to the treatment protocol: Adaptive radiotherapy according to UPRATE

Radiation: Adaptive radiotherapy according to UPRATE protocol

Interventions

Adaptive radiotherapy according to UPRATE protocol RADIATION

According to previously reported STAMPEDE trial (Parker et al.), patients will be treated with 6 weekly fractions of 6 Gy. According to local protocol the target will consist of prostate and entire seminal vesicles. Additional CT-scans will be made prior to and directly following each fraction. For more details, see study description

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven prostate cancer
• Radiologically proven limited metastatic disease
• Referred to the Erasmus MC, after multidisciplinary consensus, for local radiotherapy treatment similar to the STAMPEDE trial
• Willing to and capable of personally filling out online questionnaire
• Signed written informed consent

You may not qualify if:

• Previous pelvic radiotherapy or surgery for prostate cancer (excluding surgery to improve urinary function in benign prostate hyperplasia, i.e. trans-urethral resection of the prostate or prostatectomy according to Millin or Hryntschak)
• According to current clinical protocols at discretion of the treating physician, patients can be excluded in case of, for example, an International Prostate Symptom Score of \>20 or a prostate volume of \>90 milliliters, expecting an unacceptable rise in toxicity rates

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Centre

Rotterdam, South Holland, 3015, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Luca Incrocci, Professor

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Luca Incrocci, MD PhD, Professor of Genito-Urinary Radiotherapy

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 5, 2022
• Study Start: July 7, 2022
• Primary Completion: June 13, 2024
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

NL (1)