Brachytherapy for Recurrent Prostate Cancer (CAPRICUR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Centre Georges Francois Leclerc
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier:
NCT01956058
First received: September 26, 2013
Last updated: October 1, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Recurrent Prostate Cancer
Brachytherapy Remedial
Radiation: brachytherapy remedial
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recurrent Prostate Cancer After Irradiation Treated With Brachytherapy Remedial: Phase 2 Study

Resource links provided by NLM:


Further study details as provided by Centre Georges Francois Leclerc:

Primary Outcome Measures:
  • Toxicity occurence [ Time Frame: from the date of treatment up to 3 years of follow-up of the last patient treated ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: after the last treatment of the last patient in september 2015 (anticipated) ] [ Designated as safety issue: No ]
  • Evaluate the acute and late urinary toxicity (NCI-CTC) [ Time Frame: for each patient from the date of the intervention up to 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • colostomy and urostomy / 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: for each patient from intervention date up to 5 years of follow-up ] [ Designated as safety issue: No ]
  • The overall survival at 5 years [ Time Frame: for every patients from inclusion date up to five years of follow-up ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • The specific 5-year survival [ Time Frame: from inclusion up to 5 years of follow-up for each patient ] [ Designated as safety issue: Yes ]
  • The accumulated dose delivered to the rectum after brachytherapy remedial. [ Time Frame: after the last treatment of the last patient in september 2015 (anticipated) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: September 2013
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: brachytherapy remedial Radiation: brachytherapy remedial
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Indication of brachytherapy remedial validated
  3. Prior treatment of prostatic adenocarcinoma by radiotherapy or brachytherapy
  4. Recurrence histologically proven by biopsy within ≥ 24 months after the end of the first radiotherapy or brachytherapy
  5. Re-rise of PSA biochemical assays on three successive but with a PSA recurrence <10ng/ml
  6. Patient over 18 years
  7. WHO status 0 or 1
  8. Information informed and signed by the patient or his legal representative

Exclusion Criteria:

  1. Volume Prostate> 50 cm3
  2. proctitis and / or radiation cystitis grade ≥ 2 at the time of inclusion
  3. Initial rT3a-RT4 at the time of recurrence (clinical or MRI)
  4. Gleason score ≥ 8 (if it can be established after central review) at the time of recurrence
  5. lymph node and bone metastases
  6. invaded the seminal vesicles (diagnosed by MRI or biopsy)
  7. History of prostatectomy, TURP, or cryoablation Ablatherm ®
  8. node lymphadenectomy for "restaging" before salvage treatment
  9. IPSS> 12
  10. Getting Started with hormone therapy since the diagnosis of recurrence
  11. History of cancer within 5 years prior to entry into the trial other than basal cell skin
  12. Patient already included in another clinical trial with an experimental molecule,
  13. Persons deprived of liberty or under supervision (including guardianship)
  14. Inability to undergo medical monitoring test for geographical, social or psychological reasons.
  15. Contraindications to performing an MRI (metal prosthetic material, claustrophobia, pacemaker ...)
  16. Patient anticoagulant Plavix or under
  17. History of inflammatory bowel disease such as ulcerative colitis or Crohn's disease
  18. History of rectal surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01956058

Contacts
Contact: jérémy SKRZYPSKI, PhD 03 80 73 75 00 ext +33 jskrzypski@cgfl.fr
Contact: Marie-Christine PORTERET 03 80 73 75 00 ext +33 mcporteret@cgfl.fr

Locations
France
Centre GF Leclerc Recruiting
Dijon, France, 21079
Principal Investigator: Gilles CREHANGE, MD         
Sponsors and Collaborators
Centre Georges Francois Leclerc
  More Information

No publications provided

Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT01956058     History of Changes
Other Study ID Numbers: 2012-A01667-36
Study First Received: September 26, 2013
Last Updated: October 1, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014