Stereotactic Hypofractionated Accelerated Radiotherapy Post-Prostatectomy

NCT02976402 | Unknown Phase 1

• 1 other identifier: SHARP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The present phase I trial evaluates the feasibility of a postoperative stereotactic hypofractionated external beam radiation therapy delivered in patients who underwent radical prostatectomy with adverse pathological features or early biochemical failure. Modern computer-driven technology enables the implementation of ultra-high hypofractionated Image-Guided Radiotherapy (IGRT) safely. Eligible patients for this study are those with:

• Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy)
• Pathologic (p)T3 disease, positive margin(s), Gleason score 8-10, or seminal vesicle involvement
• Undetectable post-radical prostatectomy PSA that becomes detectable and then increases on 2 subsequent measurements (PSA of \> 0.1 - ≤ 2.0 ng/mL)
• Life expectancy: 10 years
• ECOG performance status of 0 -1
• No distant metastases, based on the following workup within 60 days prior to registration
• Magnetic resonance imaging (MRI) of the pelvis
• PSMA/Choline Positron Emission Tomography (PET) to exclude systemic disease in patients with biochemical recurrence
• Patients can be on androgen deprivation therapy
• Ability to understand and willingness to sign a study-specific informed consent prior to study. Patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility.

Conditions

Prostate Cancer Adenocarcinoma; Adjuvant Radiotherapy; Salvage Radiotherapy; SBRT; IGRT; Urethral Sparing

Outcome Measures

Primary Outcomes (1)

• Feasibility (ability to deliver radiation treatment as planned).

  Monitoring treatment related adverse events as measured by Common Toxicity Criteria for Adverse Effects v4.0

  Participants should be followed continuously, for the duration of 5 years

Secondary Outcomes (4)

• Number of participants with acute (≤ 90 days from treatment completion)treatment-related adverse events as assessed by CTCAE v4.0

  Participants should be followed continuously, for the duration of 5 years

• Number of participants with late (> 90 days from treatment completion) treatment-related adverse events as assessed by CTCAE v4.0 with SBRT administered to the prostate bed

  Participants should be followed continuously, for the duration of 5 years

• Number of participants with post-treatment quality of life impairment assessed through validated tools (EPIC)

  Participants should be followed continuously, for the duration of 5 years

• Number of participants with post-treatment abnormal laboratory values (PSA relapse)

  Participants should be followed continuously, for the duration of 5 years

Study Arms (1)

SBRT

EXPERIMENTAL

Postoperative RT consisting in: * 31 Gy in 5 sessions each of 6.2 Gy (adjuvant intent) delivered in one week * 32.5 Gy in 5 sessions each of 6.5 Gy (salvage intent) delivered in one week

Radiation: SBRT

Interventions

SBRT RADIATION

Postoperative RT consisting in: * 31 Gy in 5 sessions each of 6.2 Gy (adjuvant intent) delivered in one week * 32.5 Gy in 5 sessions each of 6.5 Gy (salvage intent) delivered in one week

Also known as: Extremely Hypofractionationated Postoperative Radiotherapy for Prostate Cancer

SBRT

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy)
• Pathologic (p)T3 disease, positive margin(s), Gleason score 8-10, or seminal vesicle involvement
• Undetectable post-radical prostatectomy PSA that becomes detectable and then increases on 2 subsequent measurements (PSA of \> 0.1 - ≤ 2.0 ng/mL)
• Life expectancy: 10 years
• ECOG performance status of 0 -1
• No distant metastases, based on the following workup within 60 days prior to registration
• Magnetic resonance imaging (MRI) of the pelvis
• PSMA/Choline Positron Emission Tomography (PET) to exclude systemic disease in patients with biochemical recurrence
• Patients can be on androgen deprivation therapy
• Ability to understand and willingness to sign a study-specific informed consent prior to study entry

You may not qualify if:

• N1 patients are ineligible, as are those with lymph node (LN) enlargement \> 1.5 cm by computed tomography (CT) or MRI of the pelvis, unless the LN is biopsy proven to be negative.
• Gross residual disease in the prostate fossa based on imaging evidence, unless biopsy proven not to contain cancer.
• Prior radiation of any kind to the prostate gland or pelvis
• Prior brachytherapy is not allowed
• History of inflammatory colitis or other active severe comorbidities
• Patients who are on immunosuppressant medication

Sponsors & Collaborators

• Fundacao Champalimaud: lead

Study Sites (1)

Champalimaud Foundation

Lisbon, 1400-038, Portugal

RECRUITING

Study Officials

• Carlo Greco, M.D.

  Champalimaud Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuela Seixas

CONTACT

+351 965289072; manuela.seixas@fundacaochampalimaud.pt

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 29, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

PT (1)