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Official title Study Evaluating the Efficacy and the Tolerance of Pelvic-prostatic Hypo-fractionated Radiotherapy Followed by Boost in Patients With Prostate Adenocarcinoma Adverse Intermediate Risk or High Localized Risk
ClinicalTrials.gov ID: NCT03417336
What this study is testing
- What it's testing
- The standard treatment of high-risk prostatic adenocarcinoma is based on pelvic-prostatic external radiotherapy combined with concomitant and adjunctive hormone therapy for a total of 3 years. Prostatic stereotactic radiotherapy in 5 sessions is a therapeutic option currently delivered and described in multiple cohorts of patients with a tolerance comparable to normo-fractional treatments.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85, men only
You may be able to join if
- Adenocarcinoma of the prostate
- Patient with one of the following cases:
- Gleason 7 - 10 + T1c - T2b + PSA \< 50 ng/mL or
- Gleason 6 + T2c - T4 ou envahissement ≥ 50% sur les biopsies + PSA \< 50 ng/mL or
- Gleason 6 + T1c - T2b + PSA \> 20 ng/mL
You likely can't join if
- Prostate cancer of histology other than adenocarcinoma,
- Patient diagnosed with N1 during imaging or pN1,
- serum PSA level\> 100 ng / ml,
- IPSS score ≥ 12 or alpha blocker treatment,
- Prostate volume estimated on MRI or ultrasound\> 60 cc
- History of cancer in the 5 years prior to entry into the trial,
See the full eligibility criteria
- Adenocarcinoma of the prostate
- Patient with one of the following cases:
- Gleason 7 - 10 + T1c - T2b + PSA \< 50 ng/mL or
- Gleason 6 + T2c - T4 ou envahissement ≥ 50% sur les biopsies + PSA \< 50 ng/mL or
- Gleason 6 + T1c - T2b + PSA \> 20 ng/mL
- Risk of lymph node involvement\> 15%
- Patient N0, or Nx
- Prostate volume estimated on MRI or ultrasound less than 60 cc.
- Absence of pelvic lymphadenopathy ≥ 15 mm on CT or MRI extension assessment
- Lack of bone and / or visceral metastasis on CT scan and bone scintigraphy
- Hormonal treatment started maximum 90 days before the beginning of the irradiation,
- IPSS score \<12 without alpha blocker treatment
- Absence of prior pelvic radiotherapy,
- Lack of surgical treatment for prostate cancer except transurethral resection performed within 6 months before radiotherapy,
- Age ≥ 18 years and ≤ 85 years,
- WHO performance index ≤ 1,
- Estimated life expectancy\> 5 years,
- Indication of treatment with radiotherapy and validated hormone therapy in a multidisciplinary consultation meeting
- Affiliation to a social security scheme,
- Signed informed consent.
- Prostate cancer of histology other than adenocarcinoma,
- Patient diagnosed with N1 during imaging or pN1,
- serum PSA level\> 100 ng / ml,
- IPSS score ≥ 12 or alpha blocker treatment,
- Prostate volume estimated on MRI or ultrasound\> 60 cc
- History of cancer in the 5 years prior to entry into the trial,
- History of trans-urethral resection of prostate less than 6 months old,
- History of rectal surgery,
- History of pelvic irradiation,
- Patient with severe hypertension not controlled by appropriate treatment,
- Contraindication to pelvic irradiation,
- Patient not eligible for brachytherapy
- Prostate volume\> 60cc
- Urine flow measurement with max flow \<12 mL / s
- Or curative anticoagulant treatment
- Or contraindication to general anesthesia
- Patient treated with antineoplastic or drug may include methotrexate,
- Hormone therapy started\> 90 days before the first irradiation,
- Patient on immunosuppressant therapy
- Contraindication to agonists or antagonists of LHRH,
- Bilateral hip prosthesis,
- Patient already included in another therapeutic trial with an experimental molecule,
- Patient unable to cooperate during treatment,
- Persons deprived of their liberty or guardianship,
- Inability to undergo medical follow-up of the test.
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.