Malignant Neoplasm of Prostate Clinical Trial
Official title:
Stereotactic Body Radiation Therapy for cT1c - cT3a Prostate Cancer With a Low Risk of Nodal Metastases (≤ 20%, Roach Index): a Novalis Circle Phase II Prospective Randomized Trial
Verified date | May 2020 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: It is not yet known whether extreme hypofractionation is equally safe and
effective than standard radiation therapy in treating prostate cancer.
PURPOSE: This protocol presents a randomised phase II study aiming to investigate the
tolerance and disease control of extreme hypofractionated Radiation Therapy for prostate
cancer.
Status | Active, not recruiting |
Enrollment | 170 |
Est. completion date | September 2025 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Age: >18 - WHO performance status = 2 - Any patient where prophylactic lymph node irradiation is not required, i.e. risk of nodal microscopic involvement = 20% (according to Roach et al (25): "N+ (in %) = (Gleason score - 6) x 10 + 2/3 PSA at diagnosis)" - T-stage: cT1-cT3a. - Previous TURP is allowed provided there is at least 8 weeks interval with radiotherapy. - Combined hormonal treatment (Neoadjuvant-concomitant androgen deprivation, AD, for 6 months) is mandatory if two or more of the following tumour characteristics are present: =cT2c, Gleason 4+3, PSA >10 ng/ml, perineural invasion, and/or >1/3 of positive biopsies. RT shall be delivered between 2 and 3 months (+/- 1 week) after starting AD and according to the following chronologic sequence: 1. Neoadjuvant AD for 2 months (30 days of bicalutamide 50mg qd, and a 3-month slow-releasing LH-RH analog to be started 15 days after initiating bicalutamide). 2. Randomization at the end of the neoadjuvant AD period (2 months after starting AD). 3. Planning RT (to be started within 1 month after randomization (i.e., between the 2nd and 3th month after initiating AD) - Concomitant and adjuvant HT for 4 more months (a second 3-month slow-releasing LH-RH analog injection). Exclusion Criteria: - Inability to obtain a written informed consent - Patient preference to be treated with one rather than the other treatment arm. - WHO performance status > 2 - cT3b,cT4 - Gleason score =8 - Clinical N+ on metastases work-up or N+ risk >20% (Roach algorithm) - Severe urinary obstructive symptoms (IPSS symptom index >19) - Previous TURP less than 8 weeks before radiotherapy - Previous prostate surgery other than TURP |
Country | Name | City | State |
---|---|---|---|
Belgium | Onze Lieve Vrouwziekenhuis | Aalst | |
Finland | University Hospital | Turku | |
Israel | Sheba Medical Center | Ramat Gan | |
Netherlands | VU University Medical Center | Amsterdam | |
Portugal | Portuguese Institut of Oncology | Porto | |
Spain | Teknon Oncologic Institute | Barcelona | |
Spain | Hospital Universitario Sanchinarro | Madrid | |
Switzerland | University Hospital | Geneva | |
Turkey | Neolife Medical Center | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Thomas Zilli |
Belgium, Finland, Israel, Netherlands, Portugal, Spain, Switzerland, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tolerance to treatment | Tolerance to treatment (urinary, rectal, sexual): Acute (up to 90 days) and late (up to 5 years) toxicity follow-up according to NCI CTCAE version 3.0 | up to 5 years | |
Secondary | 1. Quality of life | Quality of life (EORTC QLQ-C30, Prostate cancer module EORTC QLQ-PR25) | 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years | |
Secondary | 2. Local failure | Assessed by digital rectal examination (DRE). MRI or PET-CT with choline or acetate may be a confirmatory option. Biopsy confirmation is required for those patients with exclusive local failures and candidates for local salvage. | 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years | |
Secondary | 3. Biochemical disease-free survival bDFS | Phoenix definition (PSA nadir + 2 ng/ml) | 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years | |
Secondary | 4. Metastases-free survival | Outcomes 3 or 4 - investigations PET-CT choline | 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years | |
Secondary | 5. Disease-specific survival | Alive/dead status, date and cause of death and prostate cancer disease status (outcomes 3/4 and 5). | 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years |
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