Health TrialsbyHealthPanel

Towards Optimal Treatment for High Risk Prostate Cancer

ConditionHigh Risk Prostate Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorHaaglanden Medical Centre

About this trial

The goal of this clinical trial is to combine several optimized treatments of high risk prostate cancer. The main question to answer is: is it safe to combine these optimized treatments.

* patients will be irradiated on the prostate and (elective) lymph nodes more concentrated but with fewer hospital visits (hypofractionation) * the tumor will get a higher dose * androgen deprivation therapy will be reduced as much al possible preventing side effects

Researchers will compare oncological outcome and toxicity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

T3 based on digital rectal examination AND/OR

Grade >= 4 AND/OR

PSA >=20 ug/L

Indication for elective lymph node irradiation (based on current clinical guidelines) OR N1 on imaging (with a maximum of 4 suspect lymph nodes)

Disqualifiers

Prior pelvic radiotherapy

TransUrethral Resection of the Prostate (TURP) < 3 months ago

Prostatectomy or other primary treatment for prostate cancer (e.g. HIFU, cryotherapy, etc)

contraindications to MRI

Trial design

Design model

Single group

Treatments tested in this trial

  • HYPOPRIME treatment

    Radiation

    Hypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate with elective lymph node irradiation and minimized androgen deprivation therapy

Treatment groups

207 Participants
are divided into 1 treatment group
Group A: HYPOPRIME treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Biochemical recurrence free survival

rise of PSA 2 ng/ml above nadir

Time frame
5 years
2

Late gastrointestinal and genito-urinary toxicity, and erectile dysfunction

according to CTC-AE v5

Time frame
at 6 months and 2 years

Secondary outcomes

1

Metastasis free survival

Metastasis free survival

Time frame
5 years
2

Overall survival

Overall survival

Time frame
5 years
3

Pattern of failure

based on PSMA in case of biochemical recurrence

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haaglanden Medical Centre

Lead sponsor

Tata Memorial Centre

Collaborator

Source ClinicalTrials.gov
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