This study has been transitioned to CTIS with ID 2024-511252-41-00 check the CTIS register for the current data. The aim of the current study is to extend the time to develop new disease progression in prostate cancer patients with recurrent disease…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
prostaat kanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary goal of this project is to test the hypothesis that the addition of
ADT to MDRT in well-chosen PCa patients with oligo-metastatic disease (OM)
prolongs metastasis progression-free survival (MPFS) compared to radiotherapy
alone.
Secondary outcome
The secondary goal is to gain more insight into the sensitivity of the
PSMA-PET/CT or PSMA-PET/MRI for the detection of (oligo) metastases due to low
PSA levels. For the latter, the location and size of the tumor causing
secondary biochemical progression, as determined from the PSMA-PET/CT or
PSMA-PET/MRI follow-up, will be assessed by comparing the PSMA scans before and
after treatment. Furthermore, the quality of life of patients in both arms is
examined.
other secoundary endpoints:
- 3 years PSA progression
- Start of 2nd line treatment
- Start 2nd MDRT treatment for new (progressive) oligo-metastases
- Acute and late toxicity (late toxicity up to 3 years)
- Clinical progression-free survival
- Quality of life
- Progression pattern
- Time to start of palliative ADT
- Time to castration-resistance
- Disease-specific and overall survival
- Sensitivity of the imaging modality (PSMA-PET/CT or PSMA-PET/MRI) for
patients receiving MDRT
- Predictive biomarkers
Background summary
When irradiating primary prostate cancer (in patients without metastases), it
is known that the addition of short-term hormonal therapy to radiotherapy
increases the chance of healing. Therefore, this study investigates whether the
addition of short-term hormonal therapy to radiotherapy on the metastases
improves the risk of long-term disease control
Study objective
This study has been transitioned to CTIS with ID 2024-511252-41-00 check the CTIS register for the current data.
The aim of the current study is to extend the time to develop new disease
progression in prostate cancer patients with recurrent disease in the form of
limited metastases (<5) and in some cases possibly even cure by adding 6 months
of ADT to radiotherapy. improvement of metastases progression free survival.
Study design
This is a multicentre, randomized study. A total of 280 patients will
participate in this study, equally divided between both study groups.
Intervention
Metastases direct radiotherapy to all visible metastases in both arm, 6 months
ADT in the experimental arm.
Study burden and risks
all appointments will, where possible, be combined with already scheduled
appointments in the hospital. Possible side effects of ADT in the experimental
arm while the positive influence is not yet proven. fill out the questionnaires
will take 30-45 minute for each control time point.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1. Histologically proven initial diagnosis of adenocarcinoma of the Prostate.
2. Biochemical recurrence of prostate cancer following primary local prostate
treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy
+/- prostate bed adjuvant salvage radiotherapy) according to the EAU guidelines
2018. BCR after surgery: PSA >= 0.1ng/ml. BCR after radiotherapy: PSA nadir +2
ng/ml or 3 consequent rises in PSA level (after exclusion of possible bounce
effect).
3. Minimal 1 lesion and maximum 4 lesions (bone + lymph nodes) in total,
without evidence of visceral metastases.
a. Nodal relapse (N1) in the pelvis on PSMA-PET scan with a maximum of 4
positive lymph nodes. The upper limit of the pelvis is defined as the aortic
bifurcation.
b. Nodal relapse (M1a) on PSMA-PET scan above the aortic bifurcation with a
maximum of 3 positive lymph nodes.
c. Bone relapse on PSMA-PET scan with a maximum of 3 lesions.
d. Combination of a, b, c with a maximum of 4 metastases.
4. Age >= 18 years.
5. PSMA-PET/CT scan or PSMA-PET/MRI within 60 days prior to randomization.
6. PSA < 10 ng/ml.
7. In case of chronic use of finasteride the PSA value should be < 5 ng/ml.
8. WHO performance state 0-2.
9. Signed informed consent prior to registration/randomization.
Exclusion criteria
1. Visceral metastases.
2. PSA >= 10 ng/ml.
3. PSA-doubling time <= 3 months.
4. ADT or chemotherapy for recurrent PCa.
5. Testosterone < 1.7 nmol/l.
6. Painful metastases needed pain medication (> level 1 pain medication) .
7. Invasive active cancers other than superficial non-melanoma skin cancers.
8. Inability or unwillngness to understand the information on trial-related
topics, to give informed consent or to fill out QoL questionnaires.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-511252-41-00 |
| EudraCT | EUCTR2019-003177-26-NL |
| CCMO | NL70897.042.19 |