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Trial record 42 of 149 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

Stereotactic Hypofractionated Accelerated Radiotherapy Post-Prostatectomy (SHARP)

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ClinicalTrials.gov Identifier: NCT02976402
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
Carlo Greco, MD, Fundacao Champalimaud

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Adenocarcinoma Adjuvant Radiotherapy Salvage Radiotherapy SBRT IGRT Urethral Sparing Radiation: SBRT Phase 1

Detailed Description:

The present study evaluates the feasibility of postoperative stereotactic hypofractionated external beam radiation therapy delivered in patients who underwent radical prostatectomy with adverse pathological features or early biochemical failure. Regardless the two settings (adjuvant or salvage), external beam radiation therapy for prostate cancer is usually a protracted course, since a total dose of 66 Gy to 70 Gy is needed to be effective. At the typical rate of 1.8 Gy to 2.0 Gy per treatment, it takes approximately 35 treatments over the course of 7 weeks to complete, which is very costly and extremely time consuming. On the other hand, the α/β ratio for prostate cancer has estimated to be as low as 1.5 Gy, significantly lower than the 3 Gy value estimated for late complications.Therefore, the delivery of the same equivalent total dose at 2 Gy/fraction (normalized total dose) to the prostate using a hypofractionation regimen, a part from the practical benefits of reducing the treatment cost and number of sessions for patients to radiotherapy departments, should have a sparing effect on early responding normal tissues through the reduction in the total dose delivered, as well as a reduction in the incidence of late complications. Trials investigating clinical and toxicity outcomes of moderate hypofractionation schedules in the curative setting have reached sufficient follow-up to show similar efficacy and toxicity to conventionally fractionated regimens.

Stereotactic body radiation therapy, or SBRT, is on the shortest end of the hypofractionation spectrum. It is accomplished in a five treatments. With its pinpoint accuracy, many Institutions currently use it for primary treatment at doses up to 9 Gy per treatment, leading to excellent outcomes at least at early time points.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.A rectal balloon with air filling will be used for anatomical reproducibility, while a urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking. Previously untreated patients who underwent radical prostatectomy with adverse pathologic findings will be enrolled in a phase I study, consisting of 31 Gy (5 fractions of 6.2 Gy), respectively, delivered over a 1-week period at 5 fractions per week. This dosage corresponds to 68.2 Gy (for an α/βratio estimate of 1.5 Gy), compared to 52.7 Gy (for an α/β estimate of 4 Gy) in a conventional schedule. In those who developed early biochemical failure the radiation schedule will consists in 32.5 Gy (5 fractions of 6.5 Gy), respectively, delivered over a 1-week period at 5 fractions per week. This dosage corresponds to 74.3 Gy (for an α/β ratio estimate of 1.5 Gy), compared to 56.9 Gy (for an α/β estimate of 4 Gy) in a conventional schedule.

Patients will be followed at one month post-treatment and every 3 months for up to 12 months (+/- 4 weeks) and every 6 months thereafter. Acute and chronic toxicity evaluations will focus, though not exclusively, on urinary, rectal and sexual functions and will be assessed through validated EPIC questionnaires. Serum PSA values will be drawn on the same schedule as clinical follow-up. The study will be continuously monitored for a minimum of 5 years. In the event unexpected severe (grade ≥3) toxicities are observed in any one of the treatment regimens, the trial will be terminated according to the standard stopping rules: >3/first 10, and >5/first 25 patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Hypofractionated Accelerated Radiotherapy Post-Prostatectomy: a Phase I Feasibility Study
Study Start Date : November 2016
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SBRT

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

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
Other Name: Extremely Hypofractionationated Postoperative Radiotherapy for Prostate Cancer




Primary Outcome Measures :
  1. Feasibility (ability to deliver radiation treatment as planned). [ Time Frame: Participants should be followed continuously, for the duration of 5 years ]
    Monitoring treatment related adverse events as measured by Common Toxicity Criteria for Adverse Effects v4.0


Secondary Outcome Measures :
  1. Number of participants with acute (≤ 90 days from treatment completion)treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Participants should be followed continuously, for the duration of 5 years ]
  2. 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 [ Time Frame: Participants should be followed continuously, for the duration of 5 years ]
  3. Number of participants with post-treatment quality of life impairment assessed through validated tools (EPIC) [ Time Frame: Participants should be followed continuously, for the duration of 5 years ]
  4. Number of participants with post-treatment abnormal laboratory values (PSA relapse) [ Time Frame: Participants should be followed continuously, for the duration of 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976402


Contacts
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Contact: Manuela Seixas +351 965289072 manuela.seixas@fundacaochampalimaud.pt

Locations
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Portugal
Champalimaud Foundation Recruiting
Lisboa, Portugal, 1400-038
Contact: Manuela Seixas    +351 9675289072      
Sponsors and Collaborators
Fundacao Champalimaud
Investigators
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Principal Investigator: Carlo Greco, M.D. Champalimaud Foundation

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Responsible Party: Carlo Greco, MD, M.D., Fundacao Champalimaud
ClinicalTrials.gov Identifier: NCT02976402     History of Changes
Other Study ID Numbers: SHARP
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases