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RecruitingLast updated: 12 February 2024

DIPPER: This study aims to compare whether radiation therapy delivered directly to the prostate (with or without radiation therapy to close lymph glands) is more effective than active surveillance to control cancer recurrence in people with prostate cancer who have had prior treatment, including the surgeryA multi-centre, randomised phase 2 clinical trial of early salvage radiotherapy versus surveillance on the incidence of biochemical recurrence after radical prostatectomy for men with prostate cancer, incorporating clinical and imaging-based risk stratification.

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two cohorts. In Cohort 1, participants will not undergo radiation therapy and will be seen in clinic at regular intervals by their doctor for routine check-ups and blood tests. The PSA blood test will be done every 6 months to allow surveillance for their cancer. In Cohort 2, participants will undergo specific radiation therapy to their prostate area, with or without additional radiation therapy of their pelvic lymph nodes as decided by their treating clinician. Before starting radiation therapy, participants will have a CT scan of the area where the prostate gland used to be (the prostate bed) and potentially the lymph glands related to the prostate in the pelvis to plan the radiation therapy. The radiation therapy is given over about 6 and a half weeks. Participants will need to come in for treatment 5 times a week and will have a total of 32-35 treatments. Each radiation therapy treatment will take approximately 15 minutes each day. Following the radiation therapy, review appointments and investigations will be carried out every 6 months including PSA blood testing. All participants will be asked to complete a series of questionnaires to provide information on their health and wellbeing for up to 3 years after enrolment into the study.

Conditions

This trial is treating patients with people with prostate cancer who have had prior treatment

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

Not applicable

Trial Acronym

DIPPER

More information

Trial Identifiers

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Trial sponsor

Mundipharma Pty Ltd.,Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)

Scientific Title

A multi-centre, randomised phase 2 clinical trial of early salvage radiotherapy versus surveillance on the incidence of biochemical recurrence after radical prostatectomy for men with prostate cancer, incorporating clinical and imaging-based risk stratification.

Eligibility

Inclusion

1. Previous prostate cancer diagnosis treated with radical prostatectomy
2. Post-prostatectomy biochemical recurrence (Prostate-specific antigen (PSA) 0.2 - 0.5 nanograms per milliliter) with documented 2 consecutive PSA rises taken at least 14 days apart
3. Low risk features (Gleason score less than equal to 3 plus 4 / ISUP grade group less than equal to 2 and PSA doubling time greater than 12 months)
4. Willing to complete study requirements (treatments, questionnaires etc.)
5. ECOG performance status 0 or 1
6. Estimated life expectancy greater than 7yrs
7. Prior PSMA PET/CT for investigation of early biochemical recurrence
8. Prior pelvic radiation therapy that would impact delivery of the protocol radiotherapy

Exclusion

 

1. Contraindications to radiotherapy (e.g., active inflammatory bowel disease)
2. Prior or current androgen deprivation therapy (ADT) or other systemic therapy for prostate cancer
3. Bilateral orchidectomy
4. Positive regional nodal disease (N1 positive) at radical prostatectomy
5. Evidence of metastatic disease on any imaging modality
6. History of another malignancy within 5 years prior to randomisation except for those listed
7. Concurrent illness that might jeopardise the ability to undergo study procedures
8. Participation in other clinical trials of investigational agents for treatment of prostate cancer or other diseases

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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