Early Rising PSA Endocrine Treatment Versus Chemo-endocrine Therapy- SPCG14
Status:
Active, not recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
Summary
In patients with prostate cancer (PC) who have only biochemically relapsed disease after
curative treatment (or some locally advanced PC patients), hormonal therapy remains a de
facto standard of care treatment. Adding docetaxel-based chemotherapy to a standard-of-care
hormonal therapy has an increased potential to treat prostate cancer cell clones resistant to
androgen withdrawal and to possibly shorten the duration of therapy needed to control the
disease.
This clinical trial is designed on the basis of an unmet clinical need, as well as other
factors including: 1) a consensus among investigators on endpoints for studies of patients
with a rising PSA, 2) the ability to identify subjects at high risk for developing
radiographic metastases, 3) the fact that hormonal therapy has already been shown to improve
survival when applied early in the natural history, and 4) the availability of chemotherapy
such as docetaxel that can improve survival in subjects with advanced disease.
It is our hypothesis that a more appropriate group of patients who may benefit from the
curative potential of systemic chemo-hormonal modality is that with minimal, but detectable
disease who have a high probability of developing metastatic disease, clinical symptoms and
eventually death from prostate cancer in a defined time frame. The investigators hypothesize
further that the approach is likely to be more effective at a time of minimal tumour burden,
resulting in minimization of the overall burden of therapy and better quality of life while
on treatment.
This trial will determine whether any benefit is gained by adding chemotherapy to hormonal
therapy alone in the population of subjects with a rising PSA. Two therapeutic approaches
will be compared in this two-arm randomized clinical trial. The control Arm A provides
antiandrogen (bicalutamide 150 mg x 1) alone. The experimental Arm B involves treatment with
docetaxel for 8-10 cycles and antiandrogen (bicalutamide 150 mg x 1) treatment. For the
schematic representation of study design please see Section 7.3.1.
Subjects with a rising PSA following definitive local curative therapy will be eligible, if
their PSA doubling time is < 12 months. Also PC patients planned for anti-.androgen therapy
are eligible, with the same criteria. Subjects with radiographic metastases will be excluded.
The primary endpoint of the trial is progression-free survival of subjects that do not
experience biochemical failure at 60 months from the start of therapy.
Based on the yearly number of prostate cancer patients who undergo definitive local therapies
and the estimated probabilities of relapse, upwards of 400 men (if +15% improvement) in the
Scandinavian countries are potential candidates for this approach.
Phase:
Phase 3
Details
Lead Sponsor:
Andreas Josefsson Göteborg University
Collaborator:
Sahlgrenska University Hospital, Västra götalands regionen (Huvudman)