Every year, about 700 Danish men get radiotherapy for prostate cancer with a high-risk of later progression. The risk of relapse is about 40 % after 5 - 8 years, so we need better treatment for these patients in Denmark and globally. The aim is to reduce later cancer spreading, need of hormone treatments and prostate cancer death.
DAPROCA 10 tests two possible improvements:
If a higher dose (boost) to intra-prostatic tumor lesions improves cure rates. If the radiotherapy can be given with 12 treatment fractions instead of 20 without increased side-effects.
In this randomised trial half the participants get a boost and the other half don't. Half the patients get 12 treatments, the other half 20.
To answer these questions we must include1016 participants. The trial is feasible because the technological advances in imaging and radiotherapy enables us to define the tumors in the prostate and to deliver the boost to the tumors with high precision, without increased dose to the surrounding organs.
Patients with biopsy verified PCa with no distant metastases with either
Clinical stage cT2c-T3b (UICC TNM 8th edition)
Imaging stage, T3a or T3b
≥ Gleason score 4+3, (ISUP Grade groups 3,4 or 5)
WHO performance status ≥ 2
If, for any patient related reason, an MRI cannot be performed
T4
International prostate symptom score (IPSS) ≧ 20
Factorial
Addition of focal boost and hypofractionation
RadiationAddition of focal boost to primary radiotherapy for prostate cancer in 12 or 20 fractions
Freedom from distant metastasis
Metastses is verified by PSMA scan which is recommended: * If a recurrence is suspected biochemically according to biochemical relaps accordingly to the Phoenix criteria * If a recurrence is suspected clinically, e.g: Bone pain, anemia, urinary symptoms * If recurrence is suspected by radiographic test Biopsy is also accepted and MRI, CT, bone scintigraphy, NAF-PET, ultrasound or clinical examination may also be accepted with further confirmation, e.g. biopsy or laboratory tests. If the event "distant metastasis" is based on tests without biopsy or PSMA positivity the event shall be confirmed at a multi-disciplinary tumor board.
Freedom from biochemical relapse
Phoenix criteria are used for definition of the event biochemical relapse, defined as a PSA increase of 2 ug/l from nadir. The date of recurrence is the first date with a PSA level of nadir + 2. The PSA level must be confirmed by a second PSA measurement performed at minimum two weeks later.
Time to salvage hormonal therapy
Any hormone treatment will be recorded at follow-up visits and date will be verifed by the date of treatment start in the eletronic medicins system.
Regional relapse-free survival
Regional metastses means recurrence in lymph nodes is verified by PSMA scan which is recommended: * If a recurrence is suspected biochemically according to the Phoenix criteria * If a recurrence is suspected clinically, e.g: Bone pain, anemia, urinary symp-toms * If recurrence is suspected by radiographic test Biopsy is also accepted and MRI, CT, ultrasound or clinical examination may also be accepted with further confirmation, e.g. biopsy or laboratory tests. If the event "regional metastasis" is based on tests without biopsy or PSMA positivity the event shall be confirmed at a multi-disciplinary tumor board.
Local relapse-free survival
The event local recurrence is defined as a local PSMA positive lesion. Local recurrence after definitive radiotherapy should be confirmed by biopsy from the site of suspected recurrence. MRI, CT, ultrasound or clinical examination may also be accepted with further confirmation, e.g. biopsy.
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Sygehus Lillebaelt
Collaborator
Odense University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Copenhagen University Hospital at Herlev
Collaborator
Naestved Hospital
Collaborator
Aarhus University Hospital
Collaborator
