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Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence (STEREO-RE-PRO)

Primary Purpose

Local Recurrence of Malignant Tumor of Prostate

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Stereotactic Body Radiotherapy

About this trial

This is an interventional treatment trial for Local Recurrence of Malignant Tumor of Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Biochemical recurrence occurring at least 2 years after external radiotherapy for prostatic adenocarcinoma by the Phoenix definition (PSA nadir + 2 ng/mL)
T1-T2c and PSA ≤20 ng/mL and Gleason score ≤7 at initial diagnosis of prostate cancer before the initial/first treatment.
Recurrence of prostatic adenocarcinoma proven by histology following radiotherapy by transrectal or transperineal sextant biopsies of the two lobes of the prostate, with a minimum of 12 biopsies, irrespective of Gleason score. Biopsies of the seminal vesicles are optional.
Clinical stage T1-T2 on relapse; unilateral extracapsular extension (T3a) on MRI permitted except posteriorly relative to the rectum
Estimated clinical target volume (CTV) / prostate volume < 0.5 based on imaging and biopsies
Pelvic and prostatic assessment by multiparametric MRI- Absence of pelvic or metastatic recurrence proven by choline PET scan
Performance status World Health Organization (WHO) 0-1
PSA level ≤10 ng/mL at baseline (before salvage-SBRT)
PSA doubling time >10 months
International Prostate Cancer Score (IPSS) ≤12
Uroflowmetry with a maximum flow rate >10 mL/s, a postvoid residual urine volume <150 mL, and a urine volume >150 mL.
No other anti-cancer treatment since the external radiotherapy administered as first-line treatment
No other anti-cancer treatment planned for the current recurrence
No contraindication to fiducial marker implants; haemostatic disorders must be corrected before implantation
Age >18 years
Life-expectancy greater than or equal to 5 years (Lee scale)
Patient registered with a health insurance system
Patient who has signed the informed consent form
Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.

Exclusion Criteria:

Lymph node or metastatic spread
Late post-radiotherapy urinary or gastrointestinal toxicity of grade ≥2 (following primary radiotherapy)
Other cancers in the last 5 years except for non-melanoma-type skin cancer
History of inflammatory bowel disease
Anticoagulant treatment
Contraindications to undergoing MRI
Prostate volume >80 cc
Transurethral resection of the prostate (TURP) in the 6 months before registrations
Presence of rectal telangiectasia grade 3 classified by the Vienna Rectoscopy Score (obligatory rectoscopy)
Previous rectal surgery
Patients unable to undergo medical follow-up in the study for geographical, social or psychological
Person deprived of their liberty or under protective custody or guardianship
Patients enrolled in another therapeutic study

All patients during the SBRT planning with a ratio of clinical target volume (CTV) / prostate volume >0.5 will be withdrawn from the study. These patients will be considered as not evaluable and will not be treated within the context of the study.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

SBRT at a total dose of 30 Gy

SBRT at a total dose of 25 Gy

SBRT at a total dose of 36 Gy

Arm Description

Placement of fiducials marker seeds in the prostate followed by the administration of stereotactic body radiotherapy at 30 Gy (5 sessions at a level of 6 Gy each- 1 session per day) 30 Gy is the first dose-level. During the treatment phase of the study, no study specific visits are scheduled and the patients will be followed as per standard of care.

Placement of fiducials marker seeds in the prostate followed by the administration of stereotactic body radiotherapy at 25 Gy (5 sessions at a level of 5 Gy each- 1 session per day) During the treatment phase of the study, no study specific visits are scheduled and the patients will be followed as per standard of care.

Placement of fiducials marker seeds in the prostate followed by the administration of stereotactic body radiotherapy at 36 Gy (6 sessions at a level of 6 Gy each- 1 session per day) During the treatment phase of the study, no study specific visits are scheduled and the patients will be followed as per standard of care.

Outcomes

Primary Outcome Measures

Selection of the recommended dose for salvage-SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT.

The dose-escalation part of the study will terminate once 10 patients have been treated and evaluated at a dose currently identified as the recommended dose.

Estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate

Secondary Outcome Measures

Evaluation of acute and late genitourinary toxicities of the salvage-SBRT

Acute and late genitourinary toxicities over the first 3 years according to the NCI-CTCAE V4.03 classification (June 14th, 2010)

Estimate the efficacy of the salvage-SBRT in terms of clinical progression-free survival and overall survival

Clinical progression-free survival is defined as the time interval between the date of registration and the date of clinical progression (local progression assessed by the physical examination, or appearance of metastatic lesions) or death irrespective of the cause.

Evaluation of Quality of life after salvage-SBRT

Quality of life will be evaluated based on the EORTC QLQ-C30. The Time Until Definitive Deterioration (TUDD) will be computed from registration until the first observation of a definitive deterioration of the quality of life, defined as a score decreased by 10 points (in the case of global health scale and functional scales) or increased by 10 points (in the case of symptom scales) compared to the score at baseline, without later improvement superior to 10 points compared to baseline score.

Evaluation of Quality of life after salvage-SBRT

Quality of life will be evaluated based on the EORTC QLQ-PR25. The Time Until Definitive Deterioration (TUDD) will be computed from registration until the first observation of a definitive deterioration of the quality of life, defined as a score decreased by 10 points (in the case of global health scale and functional scales) or increased by 10 points (in the case of symptom scales) compared to the score at baseline, without later improvement superior to 10 points compared to baseline score.

Full Information

NCT ID

NCT03438552

First Posted

November 14, 2017

Last Updated

October 6, 2022

Sponsor

UNICANCER

1. Study Identification

Unique Protocol Identification Number

NCT03438552

Brief Title

Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence

Acronym

STEREO-RE-PRO

Official Title

Phase I/II Multi-center Study Evaluating the Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence After External Radiation Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 18, 2018 (Actual)

Primary Completion Date

November 2024 (Anticipated)

Study Completion Date

November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Stereo-Re-Pro aims to provide further evidence of Stereotactic Body Radiotherapy (SBRT) as a supplementary non-invasive curative treatment for local recurrence following radiotherapy. The objective of the first part of the trial (Phase I) is to select the recommended dose for salvage SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT. Particular attention will be paid to the quality of life and tolerance of the treatment. The objective of the second part of the trial (phase II) is to estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate.

Detailed Description

To date, no standard local treatment exists for patients with an intraprostatic recurrence after radiotherapy. A number of treatments options exist including: radical prostatectomy, brachytherapy, High-intensity focused ultrasound (HIFU), cryotherapy, and stereotactic radiotherapy. These treatments are associated with a variety of genitourinary and gastrointestinal toxicities and complications. In recent years, stereotactic radiotherapy has been used to treat localized prostate cancer in the primary setting but also as a salvage treatment after failure of radiotherapy. The initial results of these studies are promising, with respect to survival and tolerance, but further studies are required to confirm these initial results. The objective of STEREO-RE-PRO is to prospectively evaluate salvage SBRT for intraprostatic recurrent prostate cancer after primary external radiotherapy. This study will select patients for whom there is no standard local treatment. After inclusion and non-inclusion criteria have been verified and the patient has consented, the site will register the screening and organize the baseline visit with the placement of fiducial markers within two months before the planned start of SBRT. Once the fiducial placement has been performed and all eligibility criteria fully reviewed, the site will register the patient's participation so that the bio-statistician allocates the dose of SBRT. The dose will be allocated upon a model-based estimates provided by the statistical team and confirmed by the trial steering committee. Five or six fractions, at a level of 5 or 6 Gy per session (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy), will be delivered over a maximum of 12 days to provide a total dose of 25 to 36 Gy. During the treatment phase of the study, no study specific visits are scheduled and the patients will be followed as per standard of care. A follow-up visit is planned at 6, 10, 18 weeks from the start of SBRT for safety evaluation. Subsequent follow-up visits are planned at 6, 9, 12, 18, 24, 30, and 36 months after the start of radiotherapy. Thereafter, yearly follow-up visits at 48, 60, and 72 months after starting SBRT will be planned after the initial 3-year follow-up period. M72 visit corresponds to the end of study visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Local Recurrence of Malignant Tumor of Prostate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SBRT at a total dose of 30 Gy

Arm Type

Experimental

Arm Description

Arm Title

SBRT at a total dose of 25 Gy

Arm Type

Experimental

Arm Description

Arm Title

SBRT at a total dose of 36 Gy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiotherapy

Intervention Description

This radiotherapy may be administered with the CyberKnife® or a linear accelerator allowing stereotactic radiotherapy.

Primary Outcome Measure Information:

Title

Selection of the recommended dose for salvage-SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT.

Description

The dose-escalation part of the study will terminate once 10 patients have been treated and evaluated at a dose currently identified as the recommended dose.

Time Frame

18 weeks

Title

Estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate

Time Frame

6 years

Secondary Outcome Measure Information:

Title

Evaluation of acute and late genitourinary toxicities of the salvage-SBRT

Description

Acute and late genitourinary toxicities over the first 3 years according to the NCI-CTCAE V4.03 classification (June 14th, 2010)

Time Frame

3 years

Title

Estimate the efficacy of the salvage-SBRT in terms of clinical progression-free survival and overall survival

Description

Time Frame

6 years

Title

Evaluation of Quality of life after salvage-SBRT

Description

Time Frame

6 years

Title

Evaluation of Quality of life after salvage-SBRT

Description

Time Frame

6 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Biochemical recurrence occurring at least 2 years after external radiotherapy for prostatic adenocarcinoma by the Phoenix definition (PSA nadir + 2 ng/mL) T1-T2c and PSA ≤20 ng/mL and Gleason score ≤7 at initial diagnosis of prostate cancer before the initial/first treatment. Recurrence of prostatic adenocarcinoma proven by histology following radiotherapy by transrectal or transperineal sextant biopsies of the two lobes of the prostate, with a minimum of 12 biopsies, irrespective of Gleason score. Biopsies of the seminal vesicles are optional. Clinical stage T1-T2 on relapse; unilateral extracapsular extension (T3a) on MRI permitted except posteriorly relative to the rectum Estimated clinical target volume (CTV) / prostate volume < 0.5 based on imaging and biopsies Pelvic and prostatic assessment by multiparametric MRI- Absence of pelvic or metastatic recurrence proven by choline PET scan Performance status World Health Organization (WHO) 0-1 PSA level ≤10 ng/mL at baseline (before salvage-SBRT) PSA doubling time >10 months International Prostate Cancer Score (IPSS) ≤12 Uroflowmetry with a maximum flow rate >10 mL/s, a postvoid residual urine volume <150 mL, and a urine volume >150 mL. No other anti-cancer treatment since the external radiotherapy administered as first-line treatment No other anti-cancer treatment planned for the current recurrence No contraindication to fiducial marker implants; haemostatic disorders must be corrected before implantation Age >18 years Life-expectancy greater than or equal to 5 years (Lee scale) Patient registered with a health insurance system Patient who has signed the informed consent form Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol. Exclusion Criteria: Lymph node or metastatic spread Late post-radiotherapy urinary or gastrointestinal toxicity of grade ≥2 (following primary radiotherapy) Other cancers in the last 5 years except for non-melanoma-type skin cancer History of inflammatory bowel disease Anticoagulant treatment Contraindications to undergoing MRI Prostate volume >80 cc Transurethral resection of the prostate (TURP) in the 6 months before registrations Presence of rectal telangiectasia grade 3 classified by the Vienna Rectoscopy Score (obligatory rectoscopy) Previous rectal surgery Patients unable to undergo medical follow-up in the study for geographical, social or psychological Person deprived of their liberty or under protective custody or guardianship Patients enrolled in another therapeutic study All patients during the SBRT planning with a ratio of clinical target volume (CTV) / prostate volume >0.5 will be withdrawn from the study. These patients will be considered as not evaluable and will not be treated within the context of the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Soazig NENAN

Phone

+33 (0)185 343 113

s-nenan@unicancer.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Meryem BRIHOUM

Phone

+33 (0)180 501 295

m-brihoum@unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Pasquier

Organizational Affiliation

Centre Oscar Lambret, LILLE

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre François Baclesse

City

Caen

ZIP/Postal Code

14000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emmanuel MEYER

Phone

+33(0)231 455 002

e.meyer@baclesse.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Emmanuel MEYER

Facility Name

Centre Jean Perrin

City

Clermont-Ferrand

ZIP/Postal Code

63011

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Geneviève LOOS

Phone

+33(0)473 278 142

genevieve.loos@clermont.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Geneviève LOOS

Facility Name

Centre George François Leclerc

City

Dijon

ZIP/Postal Code

21079

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Magali QUIVRIN

Phone

+33 (0)380 737 518

mquivrin@cgfl.fr

First Name & Middle Initial & Last Name & Degree

Magali QUIVRIN

Facility Name

Centre Oscar Lambret

City

Lille

ZIP/Postal Code

59020

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David PASQUIER

Phone

+ 33(0) 320 295 911

d-pasquier@o-lambret.fr

First Name & Middle Initial & Last Name & Degree

David PASQUIER

Facility Name

Centre Léon Bérard

City

Lyon

ZIP/Postal Code

69008

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal POMMIER

Phone

+33(0)478 785 166

pascal.pommier@lyon.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Pascal Pommier

Facility Name

Institut régional du Cancer de Montpellier

City

Montpellier

ZIP/Postal Code

34298 CEDEX 05

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David AZRIA

Phone

+33(0)467 613 132

david.azria@icm.unicancer.fr

First Name & Middle Initial & Last Name & Degree

David AZRIA

Facility Name

Groupe Hospitalier Pitié-Salpétrière

City

Paris

ZIP/Postal Code

75013

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe MAINGON

Phone

+33(0)184 827 276

philippe.maingon@aphp.fr

First Name & Middle Initial & Last Name & Degree

Philippe MAINGON

Facility Name

CHU de Poitiers

City

Poitiers

ZIP/Postal Code

86000

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stéphane GUERIF

Phone

+33(0)549 444 485

stephane.guerif@chu-poitiers.fr

First Name & Middle Initial & Last Name & Degree

Stéphane GUERIF

Facility Name

DE CREVOISIER Renaud

City

Rennes

ZIP/Postal Code

35042

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Renaud DE CREVOISIER

Phone

+33(0)299 253 046

r.de-crevoisier@rennes.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Renaud DE CREVOISIER

Facility Name

ICO -Site René Gauducheau

City

Saint-Herblain

ZIP/Postal Code

44805

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephane SUPIOT

Phone

+33 (0)240 679 900

stephane.supiot@ico.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Stephane SUPIOT

Facility Name

Institut de Cancérologie Lucien Neuwirth

City

Saint-Priest-en-Jarez

ZIP/Postal Code

42270

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas MAGNE

Phone

+33(0)477 917 104

nicolas.magne@icloire.fr

First Name & Middle Initial & Last Name & Degree

Nicolas MAGNE

Facility Name

CHRU Henry S.Kaplan

City

Tours

ZIP/Postal Code

37044

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guillaume JANORAY

Phone

+33(0)2 47 47 82 65

g.janoray@chu-tours.fr

First Name & Middle Initial & Last Name & Degree

Guillaume JANORAY

Facility Name

Institut de Cancérologie de Lorraine

City

Vandoeuvre-les-nancy

ZIP/Postal Code

54519

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Didier PEIFFERT

Phone

+33(0)3 83 59 84 31

d.peiffert@nancy.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Didier PEIFFERT

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

31377694

Citation

Pasquier D, Le Deley MC, Tresch E, Cormier L, Duterque M, Nenan S, Lartigau E. GETUG-AFU 31: a phase I/II multicentre study evaluating the safety and efficacy of salvage stereotactic radiation in patients with intraprostatic tumour recurrence after external radiation therapy-study protocol. BMJ Open. 2019 Aug 2;9(8):e026666. doi: 10.1136/bmjopen-2018-026666.

Results Reference

derived

Learn more about this trial

Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence

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Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence (STEREO-RE-PRO)

Local Recurrence of Malignant Tumor of Prostate

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial