Brachytherapy for Recurrent Prostate Cancer (CAPRICUR)
Primary Purpose
Recurrent Prostate Cancer, Brachytherapy Remedial
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
brachytherapy remedial
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- localized prostate adenocarcinoma who presented as baseline characteristics: PSA ≤ 20ng/ml (with a rate of increase <2ng/ml/an in the 18 months preceding the biopsy diagnosis), Gleason score ≤ 7 and T1c to t2c.
- Indication of brachytherapy remedial validated
- Prior treatment of prostatic adenocarcinoma by radiotherapy or brachytherapy
- Recurrence histologically proven by biopsy within ≥ 24 months after the end of the first radiotherapy or brachytherapy
- Re-rise of PSA biochemical assays on three successive but with a PSA recurrence <10ng/ml
- Patient over 18 years
- WHO status 0 or 1
- Information informed and signed by the patient or his legal representative
Exclusion Criteria:
- Volume Prostate> 50 cm3
- proctitis and / or radiation cystitis grade ≥ 2 at the time of inclusion
- Initial rT3a-RT4 at the time of recurrence (clinical or MRI)
- Gleason score ≥ 8 (if it can be established after central review) at the time of recurrence
- lymph node and bone metastases
- invaded the seminal vesicles (diagnosed by MRI or biopsy)
- History of prostatectomy, TURP, or cryoablation Ablatherm ®
- node lymphadenectomy for "restaging" before salvage treatment
- IPSS> 12
- Getting Started with hormone therapy since the diagnosis of recurrence
- History of cancer within 5 years prior to entry into the trial other than basal cell skin
- Patient already included in another clinical trial with an experimental molecule,
- Persons deprived of liberty or under supervision (including guardianship)
- Inability to undergo medical monitoring test for geographical, social or psychological reasons.
- Contraindications to performing an MRI (metal prosthetic material, claustrophobia, pacemaker ...)
- Patient anticoagulant Plavix or under
- History of inflammatory bowel disease such as ulcerative colitis or Crohn's disease
- History of rectal surgery
Sites / Locations
- Centre GF Leclerc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
brachytherapy remedial
Arm Description
Outcomes
Primary Outcome Measures
Toxicity occurence
The main objective of the study is to assess the occurrence of rectal and urinary toxicities grade ≥ 3 occurred within 3 years after brachytherapy remedial
Secondary Outcome Measures
Investigate the observance of the injection of hyaluronic acid after surgery.
Evaluate the acute and late urinary toxicity (NCI-CTC)
Assess sexual toxicities by self-administered questionnaire (IIEF 5)
colostomy and urostomy / fistula
The percentage of colostomy and / or urostomy for fistula and time to use a surgical procedure for patients with complications (colostomy and / or urostomy for fistula)
The time until the start of palliative hormone
The overall survival at 5 years
Quality of life related to health EORTC QLQ C30 + EPIC survey.
Acute and late urinary toxicity identified by self-administered questionnaire (QLQ C30 symptomatic dimensions and questionnaire scores EPIC + IPSS)
The specific 5-year survival
The accumulated dose delivered to the rectum after brachytherapy remedial.
survival biochemical relapse-free, according to Phoenix criteria (nadir + 2 ng/ml)
Full Information
NCT ID
NCT01956058
First Posted
September 26, 2013
Last Updated
October 16, 2023
Sponsor
Centre Georges Francois Leclerc
1. Study Identification
Unique Protocol Identification Number
NCT01956058
Brief Title
Brachytherapy for Recurrent Prostate Cancer
Acronym
CAPRICUR
Official Title
Recurrent Prostate Cancer After Irradiation Treated With Brachytherapy Remedial: Phase 2 Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 26, 2013 (Actual)
Primary Completion Date
March 26, 2013 (Actual)
Study Completion Date
September 14, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
After a curative treatment by radiotherapy for localized prostate cancer, between 20% and 50% of patients may have a biological relapse as a progressive re -rise of PSA. After prostate brachytherapy with low flow, this rate is between 2% and 6%. Depending on risk factors initially present, some patients will have a micro metastatic disease at the time of re-rise, but others will have a true local recurrence purely intra-prostate. Local recurrence after radiotherapy is associated with a high incidence of distant metastatic relapse and poor overall survival. For these reasons, the possibility of offering a local treatment for this selected population of patients can have a major therapeutic interest and allow changing a situation often considered palliative to the possibility of a second curative treatment.
Currently, there is no consensus regarding the optimal management of patients with purely local recurrence after prostate irradiation at first intention. When an external radiotherapy or brachytherapy is performed as first choice in a patient with prostate cancer, several remedial treatments have been proposed, with controversial results the decision-making for clinicians and for difficult patients. These main therapeutic options remedial (surgery, cryotherapy and brachytherapy) have the potential for complications such as rectal injury, impotence or incontinence Brachytherapy is a new salvage treatment being evaluated in the United States (Phase II study of the Radiation Therapy Oncology Group No. 0526). Several retrospective trials have shown very encouraging results in terms of acute toxicity and biochemical control in the short term. Thus, a team from Mount Sinai in New York recently published for the first time 10 years retrospective results with this approach. In their experience after treatment failures with external beam radiotherapy or brachytherapy, a dose of 122 Gy was delivered over 90% of the prostate gland. Doing this they observed biochemical control rates and survival specific of 54 % and 96 %, respectively at 10 years, with an hormone treatment associated (median 6 months) in 84 % of cases. Four patients had grade 3 toxicity or higher (11%). To reduce the rate of late toxicities the team from the University Of California San Francisco (UCSF), tested focal brachytherapy guided by functional MRI (MRI spectroscopy) to re-treat local recurrence after initial brachytherapy as monotherapy or boost. By delivering 144 Gy on recidivism objectified on MRI, the authors observed that a minimal dose of 37Gy covered 90 % of the prostate gland to treat the risk of microscopic disease. Doing this, the rate of observed toxicities and biochemical control appeared encouraging, with a median follow-up of 2 years, since no grade 3 toxicity was observed and 74% of patients achieved a PSA nadir <0.5 ng / mL without associated hormone. In case of external radiation or brachytherapy, several attempts proposed to associate an injection of hyaluronic acid gel to the prostate - rectum interface to spare healthy tissue irradiated and thus reduce the rate of radiation proctitis. The feasibility of implementing this gel has been demonstrated in patients with non- irradiated tissues. No inherent toxicity of the injection of hyaluronic acid gel has been described after prostate brachytherapy first line. The feasibility of this injection remains unproven to date on patients previously irradiated externally or by brachytherapy. We hypothesize that the risk of radiation proctitis and fistulas front prostate could be reduced using this technique in this indication.
We propose to carry out a French prospective multicenter phase II trial combining brachytherapy remedial with an injection of hyaluronic acid after surgery to reduce the risk of radiation proctitis and / or recto -urinary fistula in a patient population hyper- selected with a high probability of isolated local recurrence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Prostate Cancer, Brachytherapy Remedial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
brachytherapy remedial
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
brachytherapy remedial
Intervention Description
brachytherapy remedial will be performed with injection of hyaluronic acid gel to interface prostate / rectum to push the rectum back and protect it from radiation.
Primary Outcome Measure Information:
Title
Toxicity occurence
Description
The main objective of the study is to assess the occurrence of rectal and urinary toxicities grade ≥ 3 occurred within 3 years after brachytherapy remedial
Time Frame
from the date of treatment up to 3 years of follow-up of the last patient treated
Secondary Outcome Measure Information:
Title
Investigate the observance of the injection of hyaluronic acid after surgery.
Time Frame
after the last treatment of the last patient in september 2015 (anticipated)
Title
Evaluate the acute and late urinary toxicity (NCI-CTC)
Time Frame
for each patient from the date of the intervention up to 5 years
Title
Assess sexual toxicities by self-administered questionnaire (IIEF 5)
Time Frame
for each patient every 3 months the first year following the interverntion and then evey six months up to five years
Title
colostomy and urostomy / fistula
Description
The percentage of colostomy and / or urostomy for fistula and time to use a surgical procedure for patients with complications (colostomy and / or urostomy for fistula)
Time Frame
for each patient from the date of intervention up to the date of colostomy and / or urostomy for fistula during the follow-up period of 5 years
Title
The time until the start of palliative hormone
Time Frame
for each patient from intervention date up to 5 years of follow-up
Title
The overall survival at 5 years
Time Frame
for every patients from inclusion date up to five years of follow-up
Title
Quality of life related to health EORTC QLQ C30 + EPIC survey.
Time Frame
for each patient every 3 months the first year following the interverntion and then evey six months up to five years
Title
Acute and late urinary toxicity identified by self-administered questionnaire (QLQ C30 symptomatic dimensions and questionnaire scores EPIC + IPSS)
Time Frame
for each patient every 3 months the first year following the interverntion and then evey six months up to five years
Title
The specific 5-year survival
Time Frame
from inclusion up to 5 years of follow-up for each patient
Title
The accumulated dose delivered to the rectum after brachytherapy remedial.
Time Frame
after the last treatment of the last patient in september 2015 (anticipated)
Title
survival biochemical relapse-free, according to Phoenix criteria (nadir + 2 ng/ml)
Time Frame
from the date of intervention up to 5 years of follow-up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
localized prostate adenocarcinoma who presented as baseline characteristics: PSA ≤ 20ng/ml (with a rate of increase <2ng/ml/an in the 18 months preceding the biopsy diagnosis), Gleason score ≤ 7 and T1c to t2c.
Indication of brachytherapy remedial validated
Prior treatment of prostatic adenocarcinoma by radiotherapy or brachytherapy
Recurrence histologically proven by biopsy within ≥ 24 months after the end of the first radiotherapy or brachytherapy
Re-rise of PSA biochemical assays on three successive but with a PSA recurrence <10ng/ml
Patient over 18 years
WHO status 0 or 1
Information informed and signed by the patient or his legal representative
Exclusion Criteria:
Volume Prostate> 50 cm3
proctitis and / or radiation cystitis grade ≥ 2 at the time of inclusion
Initial rT3a-RT4 at the time of recurrence (clinical or MRI)
Gleason score ≥ 8 (if it can be established after central review) at the time of recurrence
lymph node and bone metastases
invaded the seminal vesicles (diagnosed by MRI or biopsy)
History of prostatectomy, TURP, or cryoablation Ablatherm ®
node lymphadenectomy for "restaging" before salvage treatment
IPSS> 12
Getting Started with hormone therapy since the diagnosis of recurrence
History of cancer within 5 years prior to entry into the trial other than basal cell skin
Patient already included in another clinical trial with an experimental molecule,
Persons deprived of liberty or under supervision (including guardianship)
Inability to undergo medical monitoring test for geographical, social or psychological reasons.
Contraindications to performing an MRI (metal prosthetic material, claustrophobia, pacemaker ...)
Patient anticoagulant Plavix or under
History of inflammatory bowel disease such as ulcerative colitis or Crohn's disease
History of rectal surgery
Facility Information:
Facility Name
Centre GF Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
Learn more about this trial
Brachytherapy for Recurrent Prostate Cancer
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